<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03809052</url>
  </required_header>
  <id_info>
    <org_study_id>GB1211-001</org_study_id>
    <secondary_id>2018-003914-41</secondary_id>
    <secondary_id>Covance Study Number: 8392356</secondary_id>
    <nct_id>NCT03809052</nct_id>
  </id_info>
  <brief_title>A First in Human Study to Evaluate the Safety, Tolerability and PK of GB1211 in Healthy Subjects</brief_title>
  <official_title>GB1211 - A Randomised, Double-Blind, Placebo-Controlled, First-In-Human, Study of Orally Administered GB1211 to Evaluate the Safety, Tolerability, and PK of Single Ascending Doses (SAD) and Multiple Ascending Doses (MAD) in Healthy Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Galecto Biotech AB</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Galecto Biotech AB</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This was a Phase 1, randomized, double-blind, placebo-controlled, first-in-human study in&#xD;
      which the safety, tolerability, and pharmacokinetics of orally administered GB1211 will be&#xD;
      evaluated in healthy adult subjects and adult subjects with indication of suspected&#xD;
      Nonalcoholic steatohepatitis (NASH) and liver fibrosis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study consisted of 2 parts: a SAD phase (Part A) which enrolled a total of 5 cohorts of&#xD;
      healthy subjects and a MAD phase (Part B) which enrolled 2 cohorts of healthy subjects. Two&#xD;
      additional cohorts A6 and A7, were added following dose escalation analysis.&#xD;
&#xD;
      The planned optional Part C was to include a multiple-dose cohort of 25 subjects with&#xD;
      suspected NASH and liver fibrosis (Cohort C1). However, Part C of the study was not performed&#xD;
      as per Sponsor's decision.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 14, 2019</start_date>
  <completion_date type="Actual">June 25, 2019</completion_date>
  <primary_completion_date type="Actual">June 25, 2019</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <intervention_model_description>Part A: 56 subjects will be studied in 7 cohorts (Cohorts A1 to A7) Part B: 22 subjects will be studied in 2 cohorts (Cohorts B1 to B2)</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With of Adverse Events (AEs)</measure>
    <time_frame>Up to 5-7 days post final dose (Part A: Single dose), Part B: 6-7 weeks</time_frame>
    <description>The number of participants in each arm that report Adverse Events (AEs)</description>
  </primary_outcome>
  <number_of_arms>11</number_of_arms>
  <enrollment type="Actual">78</enrollment>
  <condition>Safety and Tolerability</condition>
  <arm_group>
    <arm_group_label>A1 - 5 mg GB1211 single dose and Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>6 healthy subjects are administered 5 mg of GB1211 capsules orally as a single dose in the fasted state. 2 subjects receive placebo. 2 subjects (1 active and 1 placebo) will be dosed at least 24 hours before the remaining subjects, where continuation to dose the remaining subjects will be at the Investigator's discretion.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>A2 - 20 mg GB1211 single dose and Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>6 healthy subjects are administered 20 mg of GB1211 capsules orally as a single dose in the fasted state. 2 subjects receive placebo. 2 subjects (1 active and 1 placebo) will be dosed at least 24 hours before the remaining subjects, where continuation to dose the remaining subjects will be at the Investigator's discretion.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>A3 - 50 mg GB1211 single dose (food effect cohort) and Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>6 healthy subjects are administered 50 mg of GB1211 capsules orally as a single dose. 2 subjects receive placebo. 2 subjects (1 active and 1 placebo) will be dosed at least 24 hours before the remaining subjects, where continuation to dose the remaining subjects will be at the Investigator's discretion. Each subject will participate in 2 treatment periods separated by a minimum of 7 days. In Treatment Period 1 doses will be administered in the fasted state, in Treatment Period 2 doses will be administered 30 minutes after the start of a high fat breakfast. Subjects will receive the same treatment in both periods.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>A4 - 100 mg GB1211 single dose and Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>6 healthy subjects are administered 100 mg of GB1211 capsules orally as a single dose in the fasted state. 2 subjects receive placebo. 2 subjects (1 active and 1 placebo) will be dosed at least 24 hours before the remaining subjects, where continuation to dose the remaining subjects will be at the Investigator's discretion.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>A5 - 200 mg GB1211 single dose and Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>6 healthy subjects are administered 200 mg of GB1211 capsules orally as a single dose in the fasted state. 2 subjects receive placebo. 2 subjects (1 active and 1 placebo) will be dosed at least 24 hours before the remaining subjects, where continuation to dose the remaining subjects will be at the Investigator's discretion.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>B1 - GB1211 multiple ascending doses, 50mg BID and Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>GB1211 administered orally twice daily over 10 days. 8 healthy subjects received GB1211 and 3 subjects will receive placebo. Following review of data in Part A (Cohorts A1 to A6), subjects received twice daily (BID) doses under fasted conditions on Days 1 to 9, inclusive, and a final single dose administration on the morning of Day 10 in accordance with the randomisation schedule.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>B2 - GB1211 multiple ascending doses, 100mg BID and Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>GB1211 administered orally twice daily over 10 days. 8 healthy subjects received GB1211 and 3 subjects will receive placebo. Following review of data in Part A (Cohorts A1 to A6), subjects received twice daily (BID) doses under fasted conditions on Days 1 to 9, inclusive, and a final single dose administration on the morning of Day 10 in accordance with the randomisation schedule..</description>
  </arm_group>
  <arm_group>
    <arm_group_label>A6 - 50mg GB1211 single dose and Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>8 healthy subjects are administered 50 mg (10 x 5mg capsules) or placebo without sentinel dosing. Optional cohort, as was added following dose-escalation analysis.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>A7 - 400 mg GB1211 single dose and Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>8 healthy subjects are administered 400 mg (8 x 50mg capsules) or placebo without sentinel dosing. Optional cohort, as was added following dose-escalation analysis.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part A - Placebo for GB1211</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In Part A - 2 subjects from each arm (A1-A5) will receive placebo.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part B - Placebo for GB1211 (BID)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Part B - 3 subjects from each arm B1 and B2 will receive placebo.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>GB1211</intervention_name>
    <description>Hard capsules for oral use</description>
    <arm_group_label>A1 - 5 mg GB1211 single dose and Placebo</arm_group_label>
    <arm_group_label>A2 - 20 mg GB1211 single dose and Placebo</arm_group_label>
    <arm_group_label>A3 - 50 mg GB1211 single dose (food effect cohort) and Placebo</arm_group_label>
    <arm_group_label>A4 - 100 mg GB1211 single dose and Placebo</arm_group_label>
    <arm_group_label>A5 - 200 mg GB1211 single dose and Placebo</arm_group_label>
    <arm_group_label>A6 - 50mg GB1211 single dose and Placebo</arm_group_label>
    <arm_group_label>A7 - 400 mg GB1211 single dose and Placebo</arm_group_label>
    <arm_group_label>B1 - GB1211 multiple ascending doses, 50mg BID and Placebo</arm_group_label>
    <arm_group_label>B2 - GB1211 multiple ascending doses, 100mg BID and Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Hard capsules for oral use</description>
    <arm_group_label>Part A - Placebo for GB1211</arm_group_label>
    <arm_group_label>Part B - Placebo for GB1211 (BID)</arm_group_label>
    <other_name>GB1211</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Subjects for Parts A and B must satisfy all of the following criteria at the Screening&#xD;
        visit unless otherwise stated:&#xD;
&#xD;
          1. Males or females, of any race, between 18 and 55 years of age (60 years for Part B),&#xD;
             inclusive.&#xD;
&#xD;
          2. Body mass index (BMI) of 18.0 to 32.0 kg/m^2 (inclusive) with a minimum body weight of&#xD;
             50 kg.&#xD;
&#xD;
          3. In good health, determined by no clinically significant findings from medical history,&#xD;
             physical examination, 12-lead ECG, vital signs measurements, and clinical laboratory&#xD;
             evaluations&#xD;
&#xD;
          4. Females will not be pregnant or lactating, and females of childbearing potential and&#xD;
             males will agree to use contraception as detailed further in the protocol.&#xD;
&#xD;
          5. Male subjects must agree to refrain from sperm donation and females should refrain&#xD;
             from ova donation from the date of Check-in (Day -1) until 90 days after the Follow-up&#xD;
             visit.&#xD;
&#xD;
          6. Able to comprehend and willing to sign an ICF and to abide by the study restrictions.&#xD;
&#xD;
        Subjects for Parts C must satisfy all of the following criteria at the Screening visit&#xD;
        unless otherwise stated:&#xD;
&#xD;
          1. Males or females, of any race, between 18 and 60 years of age, inclusive.&#xD;
&#xD;
          2. Body mass index (BMI) of ≥ 25.0 and ≤ 38.0 kg/m^2.&#xD;
&#xD;
          3. Documented history of fatty liver within the last 24 weeks by one of the following:&#xD;
             magnetic resonance imaging (MRI) suggesting liver fat ≥ 8%, ultrasound (US) indicating&#xD;
             fatty liver, or Fibroscan Controlled Attenuation Parameter (CAP) &gt; 270 dB/m. In&#xD;
             subjects without a documented history of fatty liver, a Fibroscan CAP or US can be&#xD;
             performed at Screening. Subjects with Fibroscan CAP &gt; 270 dB/m or US indicating fatty&#xD;
             liver are eligible.&#xD;
&#xD;
          4. Metabolic syndrome (Adult Treatment Panel III definition) or T2DM (defined as stable&#xD;
             diabetes with glycosylated haemoglobin [HbA1c] ≤ 9.5%).&#xD;
&#xD;
          5. Alanine aminotransferase (ALT) ≥ 20 U/L for females and ≥ 30 U/L for males at&#xD;
             Screening.&#xD;
&#xD;
          6. Fibroscan ≥ 7 KPa and &lt; 13 KPa, or Fibrosis-4 (FIB-4) index ≥ 1.1 and &lt;3.25.&#xD;
&#xD;
          7. Females of nonchildbearing potential defined as permanently sterile (ie, due to&#xD;
             hysterectomy, bilateral salpingectomy, and/or bilateral oophorectomy) or&#xD;
             postmenopausal (defined as at least 12 months postcessation of menses without an&#xD;
             alternative medical cause and follicle-stimulating hormone [FSH] level ≥ 40 mIU/mL).&#xD;
             Males will agree to use contraception as detailed in protocol.&#xD;
&#xD;
          8. Male subjects must agree to refrain from sperm donation and females should refrain&#xD;
             from ova donation from the date of Check-in (Day -1) until 90 days after the Follow-up&#xD;
             visit.&#xD;
&#xD;
          9. Able to comprehend and willing to sign an ICF and to abide by the study restrictions.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Subjects from Part A &amp; B will be excluded from the study if they satisfy any of the&#xD;
        following criteria at the Screening visit unless otherwise stated:&#xD;
&#xD;
          1. Significant history or clinical manifestation of any metabolic, allergic,&#xD;
             dermatological, hepatic, renal, haematological, pulmonary, cardiovascular,&#xD;
             gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as&#xD;
             determined by the Investigator (or designee).&#xD;
&#xD;
          2. History of febrile illness within 7 days prior to the first dose of study drug or&#xD;
             subjects with evidence of active infection.&#xD;
&#xD;
        3 (Part A). Any of the following: a. QTcF &gt; 450 msec confirmed by repeat measurement. b.&#xD;
        QRS duration &gt; 110 msec confirmed by repeat measurement. c. PR interval &gt; 220 msec&#xD;
        confirmed by repeat measurement. d. findings which would make QTc measurements difficult or&#xD;
        QTc data uninterpretable. e. history of additional risk factors for torsades de pointes&#xD;
        (eg, heart failure, hypokalaemia, family history of long QT syndrome).&#xD;
&#xD;
        3 (Part B). Clinically significant ECG abnormalities or QTcF greater than 450 msec for&#xD;
        males and 470 msec for females at either Screening or Day 1 predose, or any prior history&#xD;
        of QT abnormality.&#xD;
&#xD;
        4. History of alcoholism or drug/chemical abuse within 1 year prior to Check-in.&#xD;
&#xD;
        5. Positive hepatitis panel and/or positive human immunodeficiency virus (HIV) test.&#xD;
&#xD;
        6. Participation in a clinical study involving administration of an investigational agent&#xD;
        or vaccine (new chemical entity) or having received a biological product in the past 90&#xD;
        days prior to dosing.&#xD;
&#xD;
        7. Use or intend to use any medications/products known to alter drug absorption,&#xD;
        metabolism, or elimination processes, including St. John's wort, within 30 days prior to&#xD;
        dosing, unless deemed acceptable by the Investigator (or designee).&#xD;
&#xD;
        8. Use or intend to use any prescription medications/products other than hormone&#xD;
        replacement therapy, oral, implantable, transdermal, injectable, or intrauterine&#xD;
        contraceptives within 14 days prior to dosing, unless deemed acceptable by the Investigator&#xD;
        (or designee).&#xD;
&#xD;
        9. Use of tobacco- or nicotine-containing products within 3 months prior to Check-in, or&#xD;
        positive cotinine at Screening or Check-in.&#xD;
&#xD;
        10. Receipt of blood products within 2 months prior to Check-in and donation of blood from&#xD;
        3 months prior to Screening, plasma from 2 weeks prior to Screening, or platelets from 6&#xD;
        weeks prior to Screening.&#xD;
&#xD;
        11. Subject who, in the opinion of the Investigator (or designee), should not participate&#xD;
        in this study.&#xD;
&#xD;
        Subjects from Part C will be excluded from the study if they satisfy any of the following&#xD;
        criteria at the Screening visit unless otherwise stated:&#xD;
&#xD;
          1. If diabetic and diabetes is other than T2DM.&#xD;
&#xD;
          2. Subjects, who have had bariatric surgery of any kind or, in the opinion of the&#xD;
             Investigator, have experienced a clinically significant change in body weight within&#xD;
             the 3 months prior to Screening.&#xD;
&#xD;
          3. History of any known serious disease (such as cancer, except skin basocellular&#xD;
             carcinomas, major infection, clinically significant gastrointestinal disorder, major&#xD;
             autoimmune disease) or other disease which in the Investigator's opinion would exclude&#xD;
             the patient from the study.&#xD;
&#xD;
          4. The following clinical laboratory results at Screening: -Total Bilirubin &gt; 2 × ULN,&#xD;
             ALT &gt; 155 U/L for females and &gt; 185 U/L for males, AST &gt; 155 U/L for females and &gt; 200&#xD;
             U/L for males&#xD;
&#xD;
          5. Other abnormal clinical laboratory values that are considered clinically significant&#xD;
             for this population.&#xD;
&#xD;
          6. Clinically significant ECG abnormalities or QTcF greater than 450 msec for males and&#xD;
             470 msec for females at either Screening or Day 1 predose, or any prior history of QT&#xD;
             abnormality.&#xD;
&#xD;
          7. History of alcoholism or drug/chemical abuse within 1 year prior to Check-in.&#xD;
&#xD;
          8. Alcohol consumption of &gt; 14 units per week for males and for females. One unit of&#xD;
             alcohol equals ½ pint (285 mL) of beer or lager, 1 glass (125 mL) of wine, or 1/6 gill&#xD;
             (25 mL) of spirits.&#xD;
&#xD;
          9. Positive alcohol breath test result or positive urine drug screen (confirmed by&#xD;
             repeat) at Screening or Check-in.&#xD;
&#xD;
         10. Positive hepatitis panel and/or positive HIV test .&#xD;
&#xD;
         11. A creatinine clearance of less than 50 mL/min (as calculated by Cockcroft-Gault&#xD;
             equation) or estimated glomerular filtration rate (eGFR) &lt; 60 mL/[min*1.73 m²] at&#xD;
             Screening.&#xD;
&#xD;
         12. Subject taking any antidiabetic medications, with the exception of metformin,&#xD;
             sulfonylureas, gliptins, and sodium/glucose co-transporter 2 inhibitors, within 3&#xD;
             months prior to Screening.&#xD;
&#xD;
         13. Use of any of the following non-permitted medication within 6 months prior to&#xD;
             Screening: amiodarone, bile salt chelators, methotrexate, pharmacological doses of&#xD;
             systemic corticosteroids for at least 2 consecutive weeks, or any other medications&#xD;
             known to affect liver function.&#xD;
&#xD;
         14. Have previously completed or withdrawn from this study investigating GB1211, and have&#xD;
             previously received the investigational product.&#xD;
&#xD;
         15. Subject who, in the opinion of the Investigator (or designee), should not participate&#xD;
             in this study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dr Ashley Brooks, MBChB</last_name>
    <role>Principal Investigator</role>
    <affiliation>Covance</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Dr Bertil Lindmark MD PHD, Chief Medical Officer</last_name>
    <role>Study Chair</role>
    <affiliation>Galecto Biotech AB</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>(For Parts A and B) Covance Clinical Research Unit Ltd</name>
      <address>
        <city>Leeds</city>
        <zip>LS2 9LH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>December 7, 2018</study_first_submitted>
  <study_first_submitted_qc>January 15, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 18, 2019</study_first_posted>
  <results_first_submitted>December 18, 2020</results_first_submitted>
  <results_first_submitted_qc>February 5, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">February 23, 2021</results_first_posted>
  <last_update_submitted>February 25, 2021</last_update_submitted>
  <last_update_submitted_qc>February 25, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 17, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>GB1211</keyword>
  <keyword>Phase 1</keyword>
  <keyword>First Time in Human</keyword>
  <keyword>Safety</keyword>
  <keyword>Tolerability</keyword>
  <keyword>Pharmacokinetics</keyword>
  <keyword>Single Ascending Dose (SAD)</keyword>
  <keyword>Multiple Ascending Dose (MAD)</keyword>
  <keyword>Healthy Volunteers</keyword>
  <keyword>Nonalcoholic Steatohepatitis (NASH)</keyword>
  <keyword>Liver Fibrosis</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 25, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/52/NCT03809052/SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 5, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/52/NCT03809052/Prot_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>A total of 78 subjects entered the study and were randomised to treatment, with 56 subjects in Part A and 22 subjects in Part B.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>A1 - 5 mg GB1211 Single Dose</title>
          <description>6 healthy subjects are administered 5 mg of GB1211 capsules orally as a single dose in the fasted state. 1 subject will be dosed at least 24 hours before the remaining subjects, where continuation to dose the remaining subjects will be at the Investigator's discretion.&#xD;
GB1211: Hard capsules for oral use</description>
        </group>
        <group group_id="P2">
          <title>A2 - 20 mg GB1211 Single Dose</title>
          <description>6 healthy subjects are administered 20 mg of GB1211 capsules orally as a single dose in the fasted state. 1 subject will be dosed at least 24 hours before the remaining subjects, where continuation to dose the remaining subjects will be at the Investigator's discretion.&#xD;
GB1211: Hard capsules for oral use</description>
        </group>
        <group group_id="P3">
          <title>A3 - 50 mg GB1211 Single Dose (Food Effect Cohort)</title>
          <description>6 healthy subjects are administered 50 mg of GB1211 capsules orally as a single dose in the fasted state. 1 subject will be dosed at least 24 hours before the remaining subjects, where continuation to dose the remaining subjects will be at the Investigator's discretion.&#xD;
Each subject will participate in 2 treatment periods separated by a minimum of 7 days. In Treatment Period 1 doses will be administered in the fasted state, in Treatment Period 2 doses will be administered 30 minutes after the start of a high fat breakfast. Subjects will receive the same treatment in both periods.&#xD;
GB1211: Hard capsules for oral use</description>
        </group>
        <group group_id="P4">
          <title>A4 - 100 mg GB1211 Single Dose</title>
          <description>6 healthy subjects are administered 100 mg of GB1211 capsules orally as a single dose in the fasted state. 1 subject will be dosed at least 24 hours before the remaining subjects, where continuation to dose the remaining subjects will be at the Investigator's discretion.&#xD;
GB1211: Hard capsules for oral use</description>
        </group>
        <group group_id="P5">
          <title>A5 - 200 mg GB1211 Single Dose</title>
          <description>6 healthy subjects are administered 200 mg of GB1211 capsules orally as a single dose in the fasted state. 1 subject will be dosed at least 24 hours before the remaining subjects, where continuation to dose the remaining subjects will be at the Investigator's discretion.&#xD;
GB1211: Hard capsules for oral use</description>
        </group>
        <group group_id="P6">
          <title>A6 - 50mg GB1211 Single Dose</title>
          <description>6 healthy subjects are administered 50 mg without sentinel dosing. Optional cohort, as was added following dose-escalation analysis.&#xD;
GB1211: Hard capsules for oral use</description>
        </group>
        <group group_id="P7">
          <title>A7 - 400 mg GB1211 Single Dose</title>
          <description>6 healthy subjects are administered 400 mg without sentinel dosing. Optional cohort, as was added following dose-escalation analysis.&#xD;
GB1211: Hard capsules for oral use</description>
        </group>
        <group group_id="P8">
          <title>Part A - Placebo GB1211</title>
          <description>In Part A, 14 subjects will receive placebo in total.&#xD;
Placebo: Hard capsules for oral use</description>
        </group>
        <group group_id="P9">
          <title>B1 - GB1211 Multiple Ascending Doses, 50mg BID</title>
          <description>GB1211 50 mg administered orally twice daily over 10 days. 8 healthy subjects received GB1211. Following review of data in Part A (Cohorts A1 to A6), subjects received twice daily (BID) doses under fasted conditions on Days 1 to 9, inclusive, and a final single dose administration on the morning of Day 10 in accordance with the randomisation schedule.&#xD;
GB1211: Hard capsules for oral use</description>
        </group>
        <group group_id="P10">
          <title>B2 - GB1211 Multiple Ascending Doses, 100mg BID</title>
          <description>GB1211 100 mg administered orally twice daily over 10 days. 8 healthy subjects received GB1211. Following review of data in Part A (Cohorts A1 to A6), subjects received twice daily (BID) doses under fasted conditions on Days 1 to 9, inclusive, and a final single dose administration on the morning of Day 10 in accordance with the randomisation schedule.&#xD;
GB1211: Hard capsules for oral use</description>
        </group>
        <group group_id="P11">
          <title>Part B - PLacebo GB1211 (BID)</title>
          <description>In Part B, 6 subjects will receive placebo in total.&#xD;
Placebo: Hard capsules for oral use</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="6"/>
                <participants group_id="P5" count="6"/>
                <participants group_id="P6" count="6"/>
                <participants group_id="P7" count="6"/>
                <participants group_id="P8" count="14"/>
                <participants group_id="P9" count="8"/>
                <participants group_id="P10" count="8"/>
                <participants group_id="P11" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="6"/>
                <participants group_id="P5" count="6"/>
                <participants group_id="P6" count="6"/>
                <participants group_id="P7" count="6"/>
                <participants group_id="P8" count="14"/>
                <participants group_id="P9" count="8"/>
                <participants group_id="P10" count="8"/>
                <participants group_id="P11" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>A1 - 5 mg GB1211 Single Dose</title>
          <description>6 healthy subjects are administered 5 mg of GB1211 capsules orally as a single dose in the fasted state. 1 subject will be dosed at least 24 hours before the remaining subjects, where continuation to dose the remaining subjects will be at the Investigator's discretion.&#xD;
GB1211: Hard capsules for oral use</description>
        </group>
        <group group_id="B2">
          <title>A2 - 20 mg GB1211 Single Dose</title>
          <description>6 healthy subjects are administered 20 mg of GB1211 capsules orally as a single dose in the fasted state. 1 subject will be dosed at least 24 hours before the remaining subjects, where continuation to dose the remaining subjects will be at the Investigator's discretion.&#xD;
GB1211: Hard capsules for oral use</description>
        </group>
        <group group_id="B3">
          <title>A3 - 50 mg GB1211 Single Dose (Food Effect Cohort)</title>
          <description>6 healthy subjects are administered 50 mg of GB1211 capsules orally as a single dose in the fasted state. 1 subject will be dosed at least 24 hours before the remaining subjects, where continuation to dose the remaining subjects will be at the Investigator's discretion.&#xD;
GB1211: Hard capsules for oral use</description>
        </group>
        <group group_id="B4">
          <title>A4 - 100 mg GB1211 Single Dose</title>
          <description>6 healthy subjects are administered 100 mg of GB1211 capsules orally as a single dose in the fasted state. 1 subject will be dosed at least 24 hours before the remaining subjects, where continuation to dose the remaining subjects will be at the Investigator's discretion.&#xD;
GB1211: Hard capsules for oral use</description>
        </group>
        <group group_id="B5">
          <title>A5 - 200 mg GB1211 Single Dose</title>
          <description>6 healthy subjects are administered 200 mg of GB1211 capsules orally as a single dose in the fasted state. 1 subject will be dosed at least 24 hours before the remaining subjects, where continuation to dose the remaining subjects will be at the Investigator's discretion.&#xD;
GB1211: Hard capsules for oral use</description>
        </group>
        <group group_id="B6">
          <title>A6 - 50mg GB1211 Single Dose</title>
          <description>6 healthy subjects are administered 50 mg without sentinel dosing. Optional cohort, as was added following dose-escalation analysis.&#xD;
GB1211: Hard capsules for oral use</description>
        </group>
        <group group_id="B7">
          <title>A7 - 400 mg GB1211 Single Dose</title>
          <description>6 healthy subjects are administered 400 mg without sentinel dosing. Optional cohort, as was added following dose-escalation analysis.&#xD;
GB1211: Hard capsules for oral use</description>
        </group>
        <group group_id="B8">
          <title>Part A - Placebo for GB1211</title>
          <description>In Part A, 14 subjects will receive placebo in total.&#xD;
Placebo: Hard capsules for oral use Placebo: Hard capsules for oral use</description>
        </group>
        <group group_id="B9">
          <title>B1 - GB1211 Multiple Ascending Doses, 50mg BID</title>
          <description>GB1211 50mg administered orally twice daily over 10 days. 8 healthy subjects received GB1211. Following review of data in Part A (Cohorts A1 to A6), subjects received twice daily (BID) doses under fasted conditions on Days 1 to 9, inclusive, and a final single dose administration on the morning of Day 10 in accordance with the randomisation schedule.&#xD;
GB1211: Hard capsules for oral use</description>
        </group>
        <group group_id="B10">
          <title>B2 - GB1211 Multiple Ascending Doses, 100mg BID</title>
          <description>GB1211 100mg administered orally twice daily over 10 days. 8 healthy subjects received GB1211. Following review of data in Part A (Cohorts A1 to A6), subjects received twice daily (BID) doses under fasted conditions on Days 1 to 9, inclusive, and a final single dose administration on the morning of Day 10 in accordance with the randomisation schedule.&#xD;
GB1211: Hard capsules for oral use</description>
        </group>
        <group group_id="B11">
          <title>Part B - Placebo for GB1211 (BID)</title>
          <description>In Part B, 6 subjects will receive placebo in total.&#xD;
Placebo: Hard capsules for oral use&#xD;
Placebo: Hard capsules for oral use</description>
        </group>
        <group group_id="B12">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="6"/>
            <count group_id="B2" value="6"/>
            <count group_id="B3" value="6"/>
            <count group_id="B4" value="6"/>
            <count group_id="B5" value="6"/>
            <count group_id="B6" value="6"/>
            <count group_id="B7" value="6"/>
            <count group_id="B8" value="14"/>
            <count group_id="B9" value="8"/>
            <count group_id="B10" value="8"/>
            <count group_id="B11" value="6"/>
            <count group_id="B12" value="78"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="34" spread="7.4"/>
                    <measurement group_id="B2" value="38" spread="12.8"/>
                    <measurement group_id="B3" value="28" spread="8.0"/>
                    <measurement group_id="B4" value="35" spread="9.2"/>
                    <measurement group_id="B5" value="36" spread="12.8"/>
                    <measurement group_id="B6" value="34" spread="13.5"/>
                    <measurement group_id="B7" value="39" spread="11.3"/>
                    <measurement group_id="B8" value="37" spread="13.3"/>
                    <measurement group_id="B9" value="42" spread="12.6"/>
                    <measurement group_id="B10" value="37" spread="11.6"/>
                    <measurement group_id="B11" value="39" spread="8.1"/>
                    <measurement group_id="B12" value="36" spread="11.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="2"/>
                    <measurement group_id="B7" value="2"/>
                    <measurement group_id="B8" value="6"/>
                    <measurement group_id="B9" value="3"/>
                    <measurement group_id="B10" value="3"/>
                    <measurement group_id="B11" value="2"/>
                    <measurement group_id="B12" value="27"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="5"/>
                    <measurement group_id="B5" value="5"/>
                    <measurement group_id="B6" value="4"/>
                    <measurement group_id="B7" value="4"/>
                    <measurement group_id="B8" value="8"/>
                    <measurement group_id="B9" value="5"/>
                    <measurement group_id="B10" value="5"/>
                    <measurement group_id="B11" value="4"/>
                    <measurement group_id="B12" value="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="6"/>
                    <measurement group_id="B6" value="6"/>
                    <measurement group_id="B7" value="6"/>
                    <measurement group_id="B8" value="14"/>
                    <measurement group_id="B9" value="8"/>
                    <measurement group_id="B10" value="8"/>
                    <measurement group_id="B11" value="6"/>
                    <measurement group_id="B12" value="78"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="3"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="5"/>
                    <measurement group_id="B5" value="6"/>
                    <measurement group_id="B6" value="5"/>
                    <measurement group_id="B7" value="6"/>
                    <measurement group_id="B8" value="11"/>
                    <measurement group_id="B9" value="8"/>
                    <measurement group_id="B10" value="8"/>
                    <measurement group_id="B11" value="6"/>
                    <measurement group_id="B12" value="68"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight</title>
          <units>kilogram</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="75.9" spread="7.27"/>
                    <measurement group_id="B2" value="77.9" spread="19.03"/>
                    <measurement group_id="B3" value="71.4" spread="7.87"/>
                    <measurement group_id="B4" value="75.1" spread="13.94"/>
                    <measurement group_id="B5" value="73.7" spread="11.61"/>
                    <measurement group_id="B6" value="73.3" spread="16.72"/>
                    <measurement group_id="B7" value="79.7" spread="12.63"/>
                    <measurement group_id="B8" value="81.3" spread="12.82"/>
                    <measurement group_id="B9" value="85.4" spread="17.20"/>
                    <measurement group_id="B10" value="76.8" spread="9.52"/>
                    <measurement group_id="B11" value="70.9" spread="13.24"/>
                    <measurement group_id="B12" value="76.5" spread="12.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Height</title>
          <units>centimeter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="172.3" spread="10.31"/>
                    <measurement group_id="B2" value="171.7" spread="9.65"/>
                    <measurement group_id="B3" value="169.8" spread="5.00"/>
                    <measurement group_id="B4" value="175.3" spread="5.20"/>
                    <measurement group_id="B5" value="174.7" spread="8.45"/>
                    <measurement group_id="B6" value="176.2" spread="12.86"/>
                    <measurement group_id="B7" value="173.7" spread="8.12"/>
                    <measurement group_id="B8" value="173.6" spread="10.26"/>
                    <measurement group_id="B9" value="178.9" spread="7.62"/>
                    <measurement group_id="B10" value="173.4" spread="4.21"/>
                    <measurement group_id="B11" value="175.2" spread="5.71"/>
                    <measurement group_id="B12" value="174.1" spread="7.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BMI</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25.9" spread="4.48"/>
                    <measurement group_id="B2" value="26.1" spread="3.91"/>
                    <measurement group_id="B3" value="24.8" spread="2.73"/>
                    <measurement group_id="B4" value="24.5" spread="4.63"/>
                    <measurement group_id="B5" value="24.1" spread="3.25"/>
                    <measurement group_id="B6" value="23.3" spread="2.86"/>
                    <measurement group_id="B7" value="26.2" spread="1.90"/>
                    <measurement group_id="B8" value="26.9" spread="3.06"/>
                    <measurement group_id="B9" value="26.5" spread="3.78"/>
                    <measurement group_id="B10" value="25.5" spread="2.35"/>
                    <measurement group_id="B11" value="23.0" spread="3.50"/>
                    <measurement group_id="B12" value="25.2" spread="3.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With of Adverse Events (AEs)</title>
        <description>The number of participants in each arm that report Adverse Events (AEs)</description>
        <time_frame>Up to 5-7 days post final dose (Part A: Single dose), Part B: 6-7 weeks</time_frame>
        <population>All subjects in part A and B were included in the safety populations. The safety population will include all subjects who received at least 1 dose of study treatment (GB1211 or placebo). Safety parameters will be listed and summarised using descriptive statistics. No formal statistical analysis of safety data is planned.</population>
        <group_list>
          <group group_id="O1">
            <title>A1 - 5 mg GB1211 Single Dose</title>
            <description>6 healthy subjects are administered 5 mg of GB1211 capsules orally as a single dose in the fasted state. 1 subject will be dosed at least 24 hours before the remaining subjects, where continuation to dose the remaining subjects will be at the Investigator's discretion.&#xD;
GB1211: Hard capsules for oral use</description>
          </group>
          <group group_id="O2">
            <title>A2 - 20 mg GB1211 Single Dose</title>
            <description>6 healthy subjects are administered 20 mg of GB1211 capsules orally as a single dose in the fasted state. 1 subject will be dosed at least 24 hours before the remaining subjects, where continuation to dose the remaining subjects will be at the Investigator's discretion.&#xD;
GB1211: Hard capsules for oral use</description>
          </group>
          <group group_id="O3">
            <title>A3 - 50 mg GB1211 Single Dose (Food Effect Cohort)</title>
            <description>6 healthy subjects are administered 50 mg of GB1211 capsules orally as a single dose. 2 subjects receive placebo. 2 subjects (1 active and 1 placebo) will be dosed at least 24 hours before the remaining subjects, where continuation to dose the remaining subjects will be at the Investigator's discretion. Each subject will participate in 2 treatment periods separated by a minimum of 7 days. In Treatment Period 1 doses will be administered in the fasted state, in Treatment Period 2 doses will be administered 30 minutes after the start of a high fat breakfast. Subjects will receive the same treatment in both periods.&#xD;
GB1211: Hard capsules for oral use</description>
          </group>
          <group group_id="O4">
            <title>A4 - 100 mg GB1211 Single Dose</title>
            <description>6 healthy subjects are administered 100 mg of GB1211 capsules orally as a single dose in the fasted state. 1 subject will be dosed at least 24 hours before the remaining subjects, where continuation to dose the remaining subjects will be at the Investigator's discretion.&#xD;
GB1211: Hard capsules for oral use</description>
          </group>
          <group group_id="O5">
            <title>A5 - 200 mg GB1211 Single Dose</title>
            <description>6 healthy subjects are administered 200 mg of GB1211 capsules orally as a single dose in the fasted state. 1 subject will be dosed at least 24 hours before the remaining subjects, where continuation to dose the remaining subjects will be at the Investigator's discretion.&#xD;
GB1211: Hard capsules for oral use</description>
          </group>
          <group group_id="O6">
            <title>A6 - 50mg GB1211 Single Dose</title>
            <description>6 healthy subjects are administered 50 mg without sentinel dosing. Optional cohort, as was added following dose-escalation analysis.&#xD;
GB1211: Hard capsules for oral use</description>
          </group>
          <group group_id="O7">
            <title>A7 - 400 mg GB1211 Single Dose</title>
            <description>6 healthy subjects are administered 400 mg without sentinel dosing. Optional cohort, as was added following dose-escalation analysis.&#xD;
GB1211: Hard capsules for oral use</description>
          </group>
          <group group_id="O8">
            <title>Part A - Placebo for GB1211</title>
            <description>In Part A, 14 subjects will receive placebo in total.&#xD;
Placebo: Hard capsules for oral use</description>
          </group>
          <group group_id="O9">
            <title>B1 - GB1211 Multiple Ascending Doses, 50mg BID</title>
            <description>GB1211 50 mg administered orally twice daily over 10 days. 8 healthy subjects received GB1211. Following review of data in Part A (Cohorts A1 to A6), subjects received twice daily (BID) doses under fasted conditions on Days 1 to 9, inclusive, and a final single dose administration on the morning of Day 10 in accordance with the randomisation schedule.&#xD;
GB1211: Hard capsules for oral use</description>
          </group>
          <group group_id="O10">
            <title>B2 - GB1211 Multiple Ascending Doses, 100mg BID</title>
            <description>GB1211 100 mg administered orally twice daily over 10 days. 8 healthy subjects received GB1211. Following review of data in Part A (Cohorts A1 to A6), subjects received twice daily (BID) doses under fasted conditions on Days 1 to 9, inclusive, and a final single dose administration on the morning of Day 10 in accordance with the randomisation schedule.&#xD;
GB1211: Hard capsules for oral use</description>
          </group>
          <group group_id="O11">
            <title>Part B - Placebo for GB1211 (BID)</title>
            <description>In Part B, 6 subjects will receive placebo in total.&#xD;
Placebo: Hard capsules for oral use</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With of Adverse Events (AEs)</title>
          <description>The number of participants in each arm that report Adverse Events (AEs)</description>
          <population>All subjects in part A and B were included in the safety populations. The safety population will include all subjects who received at least 1 dose of study treatment (GB1211 or placebo). Safety parameters will be listed and summarised using descriptive statistics. No formal statistical analysis of safety data is planned.</population>
          <units>Count of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="6"/>
                <count group_id="O7" value="6"/>
                <count group_id="O8" value="14"/>
                <count group_id="O9" value="8"/>
                <count group_id="O10" value="8"/>
                <count group_id="O11" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="2"/>
                    <measurement group_id="O7" value="1"/>
                    <measurement group_id="O8" value="5"/>
                    <measurement group_id="O9" value="1"/>
                    <measurement group_id="O10" value="4"/>
                    <measurement group_id="O11" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 5-7 days post final dose (Part A: Single dose), Part B: 6-7 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Part A - Placebo for GB1211</title>
          <description>In Part A, 14 subjects will receive placebo in total.&#xD;
Placebo: Hard capsules for oral use</description>
        </group>
        <group group_id="E2">
          <title>Part A - Placebo GB1211 (Fed)</title>
          <description>In Part A, 2 subjects will receive placebo in total in a fed state.&#xD;
Placebo: Hard capsules for oral use</description>
        </group>
        <group group_id="E3">
          <title>A1 - 5 mg GB1211 Single Dose</title>
          <description>6 healthy subjects are administered 5 mg of GB1211 capsules orally as a single dose in the fasted state. 1 subject will be dosed at least 24 hours before the remaining subjects, where continuation to dose the remaining subjects will be at the Investigator's discretion.&#xD;
GB1211: Hard capsules for oral use</description>
        </group>
        <group group_id="E4">
          <title>A2 - 20 mg GB1211 Single Dose</title>
          <description>6 healthy subjects are administered 20 mg of GB1211 capsules orally as a single dose in the fasted state. 1 subject will be dosed at least 24 hours before the remaining subjects, where continuation to dose the remaining subjects will be at the Investigator's discretion.&#xD;
GB1211: Hard capsules for oral use</description>
        </group>
        <group group_id="E5">
          <title>A3 - 50 mg GB1211 Single Dose (Period 1: Fasted)&quot; and &quot;A3- 50 mg GB1211 Single Dose (Period 2: Fed)</title>
          <description>6 healthy subjects are administered 50 mg of GB1211 capsules orally as a single dose in the fasted state. 1 subject will be dosed at least 24 hours before the remaining subjects, where continuation to dose the remaining subjects will be at the Investigator's discretion.&#xD;
GB1211: Hard capsules for oral use</description>
        </group>
        <group group_id="E6">
          <title>A6 - 50mg GB1211 Single Dose</title>
          <description>6 healthy subjects are administered 50 mg without sentinel dosing. Optional cohort, as was added following dose-escalation analysis.&#xD;
GB1211: Hard capsules for oral use</description>
        </group>
        <group group_id="E7">
          <title>A3- 50 mg GB1211 Single Dose (Fed)</title>
          <description>6 healthy subjects are administered 50 mg without sentinel dosing. Optional cohort, as was added following dose-escalation analysis.&#xD;
GB1211: Hard capsules for oral use</description>
        </group>
        <group group_id="E8">
          <title>A4 - 100 mg GB1211 Single Dose</title>
          <description>6 healthy subjects are administered 100 mg of GB1211 capsules orally as a single dose in the fasted state. 1 subject will be dosed at least 24 hours before the remaining subjects, where continuation to dose the remaining subjects will be at the Investigator's discretion.&#xD;
GB1211: Hard capsules for oral use</description>
        </group>
        <group group_id="E9">
          <title>A5 - 200 mg GB1211 Single Dose</title>
          <description>6 healthy subjects are administered 200 mg of GB1211 capsules orally as a single dose in the fasted state. 1 subject will be dosed at least 24 hours before the remaining subjects, where continuation to dose the remaining subjects will be at the Investigator's discretion.&#xD;
GB1211: Hard capsules for oral use</description>
        </group>
        <group group_id="E10">
          <title>A7 - 400 mg GB1211 Single Dose</title>
          <description>6 healthy subjects are administered 400 mg of GB1211 capsules orally as a single dose in the fasted state. 1 subject will be dosed at least 24 hours before the remaining subjects, where continuation to dose the remaining subjects will be at the Investigator's discretion.&#xD;
GB1211: Hard capsules for oral use</description>
        </group>
        <group group_id="E11">
          <title>Part B - Placebo for GB1211 (BID)</title>
          <description>In Part B, 6 subjects will receive placebo in total.&#xD;
Placebo: Hard capsules for oral use</description>
        </group>
        <group group_id="E12">
          <title>B1 - GB1211 Multiple Ascending Doses, 50mg BID</title>
          <description>GB1211 50 mg administered orally twice daily over 10 days. 8 healthy subjects received GB1211. Following review of data in Part A (Cohorts A1 to A6), subjects received twice daily (BID) doses under fasted conditions on Days 1 to 9, inclusive, and a final single dose administration on the morning of Day 10 in accordance with the randomisation schedule.&#xD;
GB1211: Hard capsules for oral use</description>
        </group>
        <group group_id="E13">
          <title>B2 - GB1211 Multiple Ascending Doses, 100mg BID</title>
          <description>GB1211 100mg administered orally twice daily over 10 days. 8 healthy subjects received GB1211. Following review of data in Part A (Cohorts A1 to A6), subjects received twice daily (BID) doses under fasted conditions on Days 1 to 9, inclusive, and a final single dose administration on the morning of Day 10 in accordance with the randomisation schedule.&#xD;
GB1211: Hard capsules for oral use</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 21.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="4" subjects_at_risk="8"/>
                <counts group_id="E13" subjects_affected="3" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Constipation</sub_title>
                <description>TEAEs reported at Part B Placebo group (1AE) and Part B B1 100mg BID group (2AEs) were determined to be drug related</description>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E13" subjects_affected="2" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <description>The TEAE was determined to be drug-related</description>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Dry mouth</sub_title>
                <description>The TEAE was determined to be drug-related</description>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <description>The TEAE was determined to be drug related</description>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <description>The TEAE was determined to be drug-related</description>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E13" subjects_affected="1" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <description>The TEAE was determined to be drug related</description>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <description>The TEAE was determined to be drug related</description>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E13" subjects_affected="1" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Medical device site reaction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Wound</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Limb injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <description>The TEAE was determined to be drug-related</description>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E13" subjects_affected="1" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E13" subjects_affected="1" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <description>The TEAE reported at Part A Placebo group was determined to be drug related. The TEAE reported on 3 subjects from Part B B1 50mg BID group were determined to be drug related</description>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="4" subjects_at_risk="8"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Pollakiuria</sub_title>
                <description>The TEAE reported to 2 subjects was determined to be tdrug related</description>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E13" subjects_affected="2" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Dysuria</sub_title>
                <description>the TEAE was determined to be drug related</description>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Menstruation irregular</sub_title>
                <description>the TEAE was determined to be drug related</description>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dry Skin</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <description>The TEAE was determined to be drug related</description>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr Bertil Lindmark, Chief Medical Officer</name_or_title>
      <organization>Galecto BIotech</organization>
      <phone>+45 70 70 52 10</phone>
      <email>info@galecto.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03809052
org study id: GB1211-001
secondary id: 2018-003914-41
secondary id: Covance Study Number: 8392356
nct id: NCT03809052
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This was a Phase 1, randomized, double-blind, placebo-controlled, first-in-human study in
      which the safety, tolerability, and pharmacokinetics of orally administered GB1211 will be
      evaluated in healthy adult subjects and adult subjects with indication of suspected
      Nonalcoholic steatohepatitis (NASH) and liver fibrosis.
The study consisted of 2 parts: a SAD phase (Part A) which enrolled a total of 5 cohorts of
      healthy subjects and a MAD phase (Part B) which enrolled 2 cohorts of healthy subjects. Two
      additional cohorts A6 and A7, were added following dose escalation analysis.

      The planned optional Part C was to include a multiple-dose cohort of 25 subjects with
      suspected NASH and liver fibrosis (Cohort C1). However, Part C of the study was not performed
      as per Sponsor's decision.
allocation: Randomized
intervention model: Sequential Assignment
intervention model description: Part A: 56 subjects will be studied in 7 cohorts (Cohorts A1 to A7) Part B: 22 subjects will be studied in 2 cohorts (Cohorts B1 to B2)
primary purpose: Other
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Number of Participants With of Adverse Events (AEs)
time frame: Up to 5-7 days post final dose (Part A: Single dose), Part B: 6-7 weeks
description: The number of participants in each arm that report Adverse Events (AEs)
arm group label: A1 - 5 mg GB1211 single dose and Placebo
arm group type: Experimental
description: 6 healthy subjects are administered 5 mg of GB1211 capsules orally as a single dose in the fasted state. 2 subjects receive placebo. 2 subjects (1 active and 1 placebo) will be dosed at least 24 hours before the remaining subjects, where continuation to dose the remaining subjects will be at the Investigator's discretion.
arm group label: A2 - 20 mg GB1211 single dose and Placebo
arm group type: Experimental
description: 6 healthy subjects are administered 20 mg of GB1211 capsules orally as a single dose in the fasted state. 2 subjects receive placebo. 2 subjects (1 active and 1 placebo) will be dosed at least 24 hours before the remaining subjects, where continuation to dose the remaining subjects will be at the Investigator's discretion.
arm group label: A3 - 50 mg GB1211 single dose (food effect cohort) and Placebo
arm group type: Experimental
description: 6 healthy subjects are administered 50 mg of GB1211 capsules orally as a single dose. 2 subjects receive placebo. 2 subjects (1 active and 1 placebo) will be dosed at least 24 hours before the remaining subjects, where continuation to dose the remaining subjects will be at the Investigator's discretion. Each subject will participate in 2 treatment periods separated by a minimum of 7 days. In Treatment Period 1 doses will be administered in the fasted state, in Treatment Period 2 doses will be administered 30 minutes after the start of a high fat breakfast. Subjects will receive the same treatment in both periods.
arm group label: A4 - 100 mg GB1211 single dose and Placebo
arm group type: Experimental
description: 6 healthy subjects are administered 100 mg of GB1211 capsules orally as a single dose in the fasted state. 2 subjects receive placebo. 2 subjects (1 active and 1 placebo) will be dosed at least 24 hours before the remaining subjects, where continuation to dose the remaining subjects will be at the Investigator's discretion.
arm group label: A5 - 200 mg GB1211 single dose and Placebo
arm group type: Experimental
description: 6 healthy subjects are administered 200 mg of GB1211 capsules orally as a single dose in the fasted state. 2 subjects receive placebo. 2 subjects (1 active and 1 placebo) will be dosed at least 24 hours before the remaining subjects, where continuation to dose the remaining subjects will be at the Investigator's discretion.
arm group label: B1 - GB1211 multiple ascending doses, 50mg BID and Placebo
arm group type: Experimental
description: GB1211 administered orally twice daily over 10 days. 8 healthy subjects received GB1211 and 3 subjects will receive placebo. Following review of data in Part A (Cohorts A1 to A6), subjects received twice daily (BID) doses under fasted conditions on Days 1 to 9, inclusive, and a final single dose administration on the morning of Day 10 in accordance with the randomisation schedule.
arm group label: B2 - GB1211 multiple ascending doses, 100mg BID and Placebo
arm group type: Experimental
description: GB1211 administered orally twice daily over 10 days. 8 healthy subjects received GB1211 and 3 subjects will receive placebo. Following review of data in Part A (Cohorts A1 to A6), subjects received twice daily (BID) doses under fasted conditions on Days 1 to 9, inclusive, and a final single dose administration on the morning of Day 10 in accordance with the randomisation schedule..
arm group label: A6 - 50mg GB1211 single dose and Placebo
arm group type: Experimental
description: 8 healthy subjects are administered 50 mg (10 x 5mg capsules) or placebo without sentinel dosing. Optional cohort, as was added following dose-escalation analysis.
arm group label: A7 - 400 mg GB1211 single dose and Placebo
arm group type: Experimental
description: 8 healthy subjects are administered 400 mg (8 x 50mg capsules) or placebo without sentinel dosing. Optional cohort, as was added following dose-escalation analysis.
arm group label: Part A - Placebo for GB1211
arm group type: Experimental
description: In Part A - 2 subjects from each arm (A1-A5) will receive placebo.
arm group label: Part B - Placebo for GB1211 (BID)
arm group type: Experimental
description: Part B - 3 subjects from each arm B1 and B2 will receive placebo.
intervention type: Drug
intervention name: GB1211
description: Hard capsules for oral use
arm group label: A1 - 5 mg GB1211 single dose and Placebo
arm group label: A2 - 20 mg GB1211 single dose and Placebo
arm group label: A3 - 50 mg GB1211 single dose (food effect cohort) and Placebo
arm group label: A4 - 100 mg GB1211 single dose and Placebo
arm group label: A5 - 200 mg GB1211 single dose and Placebo
arm group label: A6 - 50mg GB1211 single dose and Placebo
arm group label: A7 - 400 mg GB1211 single dose and Placebo
arm group label: B1 - GB1211 multiple ascending doses, 50mg BID and Placebo
arm group label: B2 - GB1211 multiple ascending doses, 100mg BID and Placebo
intervention type: Drug
intervention name: Placebo
description: Hard capsules for oral use
arm group label: Part A - Placebo for GB1211
arm group label: Part B - Placebo for GB1211 (BID)
other name: GB1211
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Dr Ashley Brooks, MBChB
role: Principal Investigator
affiliation: Covance
last name: Dr Bertil Lindmark MD PHD, Chief Medical Officer
role: Study Chair
affiliation: Galecto Biotech AB
facility: 
country: United Kingdom
responsible party type: Sponsor
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 