<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/NCT02257177</url>
  </required_header>
  <id_info>
    <org_study_id>GB-HV-01</org_study_id>
    <nct_id>NCT02257177</nct_id>
  </id_info>
  <brief_title>RCT (Randomized Control Trial) of TD139 vs Placebo in HV's (Human Volunteers) and IPF Patients</brief_title>
  <official_title>A Placebo-controlled RCT in HV's Investigating the Safety, Tolerability and PK (Pharmacokinetic) of TD139, a Galectin-3 Inhibitor, Followed by an Expansion Cohort Treating Subjects With Idiopathic Pulmonary Fibrosis (IPF)</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>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will be divided into 2 parts. Part 1 is a randomized, double-blind, single centre,&#xD;
      placebo-controlled, single ascending dose (SAD) phase I study designed to assess the safety,&#xD;
      tolerability, PK and PD (Pharmacodynamic) of TD139 in up to 36 healthy male subjects. Part 2&#xD;
      will be a randomized, double-blind, multi-centre, placebo-controlled, multiple dose expansion&#xD;
      cohort, designed to assess the safety, tolerability, PK and PD of TD139 in up to 24 male&#xD;
      subjects and female subjects of non child-bearing potential with IPF.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Up to 6 cohorts of 6 subjects will be randomly assigned in a blinded fashion to receive&#xD;
      either a single dose of TD139 or matching placebo via DPI (dry powder inhaler) in an&#xD;
      ascending dose fashion.&#xD;
&#xD;
      A single cohort of up to 24 patients will be randomly assigned in a blinded fashion to&#xD;
      receive a single dose of TD139 or placebo via DPI once daily for 14 days in a 2:1 TD139 to&#xD;
      placebo ratio. The dose of TD139 selected will be based on data from Part 1 and on&#xD;
      pre-clinical efficacy and safety data.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">December 2016</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Adverse Events</measure>
    <time_frame>0 - 30 days</time_frame>
    <description>Number of participants reporting Adverse Events from the date of first dose, until 30 days post first dose.</description>
  </primary_outcome>
  <number_of_arms>11</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Idiopathic Pulmonary Fibrosis</condition>
  <arm_group>
    <arm_group_label>0.15 mg TD139 (Part 1)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>4 Healthy Subjects are administered a single dose of 0.15mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>1.5 mg TD139 (Part 1)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>4 Healthy Subjects are administered a single dose of 1.5mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>3 mg TD139 (Part 1)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>4 Healthy Subjects are administered a single dose of 3mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>10 mg TD139 Part 1</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>4 Healthy Subjects are administered a single dose of 10mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>20 mg TD139 Part 1</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>4 Healthy Subjects are administered a single dose of 20mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>50 mg TD139 Part 1</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>4 Healthy Subjects are administered a single dose of 50mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Part 1</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>12 Healthy Subjects are administered placebo inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>0.3 mg TD139 Part 2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>5 Patients with IPF are administered a single dose of 0.3mg TD139 once daily for 14 days inhaled as a dry powder.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>3 mg TD139 Part 2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>5 Patients with IPF are administered a single dose of 3mg TD139 once daily for 14 days inhaled as a dry powder.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>10 mg TD139 Part 2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>5 Patients with IPF are administered a single dose of 10mg TD139 once daily for 14 days inhaled as a dry powder.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Part 2</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>9 Patients with IPF are administered placebo inhaled as a dry powder.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Inhaled TD139</intervention_name>
    <description>DPI Galectin-3 inhibitor</description>
    <arm_group_label>0.15 mg TD139 (Part 1)</arm_group_label>
    <arm_group_label>0.3 mg TD139 Part 2</arm_group_label>
    <arm_group_label>1.5 mg TD139 (Part 1)</arm_group_label>
    <arm_group_label>10 mg TD139 Part 1</arm_group_label>
    <arm_group_label>10 mg TD139 Part 2</arm_group_label>
    <arm_group_label>20 mg TD139 Part 1</arm_group_label>
    <arm_group_label>3 mg TD139 (Part 1)</arm_group_label>
    <arm_group_label>3 mg TD139 Part 2</arm_group_label>
    <arm_group_label>50 mg TD139 Part 1</arm_group_label>
    <other_name>TD139</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>DPI placebo</description>
    <arm_group_label>Placebo Part 1</arm_group_label>
    <arm_group_label>Placebo Part 2</arm_group_label>
    <other_name>inhaled placebo</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Part 1 Inclusion Criteria&#xD;
&#xD;
          -  Healthy male subjects aged between 18 and 55 years of age.&#xD;
&#xD;
          -  Male subject willing to use a condom, if applicable (unless anatomically sterile or&#xD;
             where abstaining from sexual intercourse is in line with the preferred and usual&#xD;
             lifestyle of the subject) from the Day 1 dose of study medication until 3 months&#xD;
             afterwards.&#xD;
&#xD;
          -  Subject with a body weight of at least 50 kg and a body mass index (BMI) within the&#xD;
             range of 18 35 kg/m2. BMI = Body weight (kg) / [Height (m)]2.&#xD;
&#xD;
          -  Subject with no clinically significant abnormal serum biochemistry, haematology and&#xD;
             urine examination values within 28 days of the Day 1 dose of study medication.&#xD;
&#xD;
          -  Subject with a negative urinary drugs of abuse screen, determined within 28 days of&#xD;
             the Day 1 dose of study medication, (N.B. a positive alcohol result may be repeated at&#xD;
             the discretion of the Investigator).&#xD;
&#xD;
          -  Subject with negative human immunodeficiency virus (HIV) and hepatitis B surface&#xD;
             antigen (Hep B) and hepatitis C virus antibody (Hep C) results.&#xD;
&#xD;
          -  Subject with no clinically significant abnormalities in 12 lead ECG determined within&#xD;
             28 days of the Day 1 dose of study medication.&#xD;
&#xD;
          -  Subjects were non smokers or former smokers (having ceased smoking for at least 6&#xD;
             months).&#xD;
&#xD;
          -  Subjects with no clinically significant impairment in oxygen saturation.&#xD;
&#xD;
          -  Subject satisfied a medical examiner about their fitness to participate in the study.&#xD;
&#xD;
          -  Subject provided written informed consent to participate in the study.&#xD;
&#xD;
          -  Subject was available to complete the study (including all follow up visits).&#xD;
&#xD;
        Confirmed at Baseline / Prior to First Dose:&#xD;
&#xD;
          -  Subject continued to meet all screening inclusion criteria.&#xD;
&#xD;
          -  Subject with a negative urinary drugs of abuse screen (including alcohol) prior to&#xD;
             dosing.&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          -  A clinically significant illness or surgery within 8 weeks prior to the Day 1 dose of&#xD;
             study medication.&#xD;
&#xD;
          -  Significant medical history that, in the Investigator's opinion, may have adversely&#xD;
             affected participation.&#xD;
&#xD;
          -  History of allergy or significant adverse reaction to drugs similar to the&#xD;
             investigational drug, to nicotine, or to cholinergic drugs or to any drugs with a&#xD;
             similar chemical structure.&#xD;
&#xD;
          -  History of hypersensitivity (anaphylaxis, angioedema) to any drug.&#xD;
&#xD;
          -  Use of any drug known to induce or inhibit hepatic drug metabolism, within 30 days&#xD;
             prior to the Day 1 dose of study medication.&#xD;
&#xD;
          -  Use of medications known to prolong QT/QTc interval within 14 days prior to the Day 1&#xD;
             dose of study medication.&#xD;
&#xD;
          -  Any clinically significant findings of physical examination or laboratory findings at&#xD;
             screening.&#xD;
&#xD;
          -  A clinically significant history of drug or alcohol abuse.&#xD;
&#xD;
          -  Receipt of regular/over the counter medication within 14 days of the Day 1 dose of&#xD;
             study medication that may have had an impact on the safety and objectives of the study&#xD;
             (at the Investigator's discretion).&#xD;
&#xD;
          -  Evidence of renal, hepatic, central nervous system, respiratory, cardiovascular or&#xD;
             metabolic dysfunction.&#xD;
&#xD;
          -  Inability to communicate well with the Investigator (i.e., language problem, poor&#xD;
             mental development or impaired cerebral function).&#xD;
&#xD;
          -  Participation in a New Chemical Entity clinical study within the previous 4 months or&#xD;
             a marketed drug clinical study within the previous 3 months. (N.B. washout period&#xD;
             between studies is defined as the period of time elapsed between the last dose of the&#xD;
             previous study and the first dose of the next study).&#xD;
&#xD;
          -  Donation of 450 mL or more blood within the previous 3 months.&#xD;
&#xD;
        Confirmed at Baseline / Prior to First Dose:&#xD;
&#xD;
          -  Development of any exclusion criteria since screening.&#xD;
&#xD;
          -  Receipt of any medication since screening that may have had an impact on the safety&#xD;
             and objectives of the study (at the Investigator's discretion).&#xD;
&#xD;
        Part 2 Inclusion Criteria&#xD;
&#xD;
          -  Male patient or female patient of non childbearing potential with IPF.&#xD;
&#xD;
          -  Male patient willing to use a condom, if applicable (unless anatomically sterile or&#xD;
             where abstaining from sexual intercourse was in line with the preferred and usual&#xD;
             lifestyle of the patient) from the first dose until at least 3 months after receiving&#xD;
             the last dose of IMP.&#xD;
&#xD;
          -  Aged between 45 and 85 years of age.&#xD;
&#xD;
          -  With a forced vital capacity (FVC) ≥ 45% predicted and forced expiratory volume in 1&#xD;
             second (FEV1)/FVC ratio ≥ 0.7.&#xD;
&#xD;
          -  Oxygen saturation &gt; 90% by pulse oximetry while breathing ambient air at rest.&#xD;
&#xD;
          -  Diffusing capacity of lungs for carbon monoxide (DLCO) &gt; 25%.&#xD;
&#xD;
          -  Had adequate organ function and a clinical diagnosis consistent with IPF prior to&#xD;
             screening (based on the American Thoracic Society, the European Respiratory Society,&#xD;
             the Japanese Respiratory Society and the Latin American Thoracic Association&#xD;
             (ATS/ERS/JRS/ALAT) consensus criteria. The diagnosis would ordinarily have been&#xD;
             confirmed at a multidisciplinary team meeting where the high resolution computed&#xD;
             tomography (HRCT) findings in particular would have been discussed with a radiologist&#xD;
             with respiratory expertise.&#xD;
&#xD;
          -  Able to undergo BAL.&#xD;
&#xD;
          -  Provided written informed consent to participate in the study.&#xD;
&#xD;
          -  Available to complete the study (including all follow up visits).&#xD;
&#xD;
          -  Negative urinary drugs of abuse screen, determined within 28 days of the first dose of&#xD;
             IMP (N.B. a positive alcohol result could have been repeated at the discretion of the&#xD;
             Investigator).&#xD;
&#xD;
          -  Negative human immunodeficiency virus (HIV) and hepatitis B surface antigen (Hep B)&#xD;
             and hepatitis C virus antibody (Hep C) results.&#xD;
&#xD;
          -  No clinically significant abnormalities in 12 lead ECG determined within 28 days of&#xD;
             the first dose of IMP.&#xD;
&#xD;
        Confirmed at Baseline / Prior to First Dose:&#xD;
&#xD;
          -  Patient continued to meet all screening inclusion criteria. Exclusion Criteria&#xD;
&#xD;
          -  Any condition that made the patient at unacceptable risk for bronchoscopy.&#xD;
&#xD;
          -  Active cigarette smoking (defined as smoking more than 3 cigarettes daily within the&#xD;
             last 6 months).&#xD;
&#xD;
          -  Presence of a significant co morbidity felt to limit life expectancy to less than 12&#xD;
             months.&#xD;
&#xD;
          -  HRCT pattern showing emphysema more than the extent of fibrosis of the lung area&#xD;
             conducted within 12 months of first dose.&#xD;
&#xD;
          -  Evidence of renal, hepatic, central nervous system, or metabolic dysfunction.&#xD;
&#xD;
          -  Evidence of poorly controlled diabetes mellitus (defined as a glycosylated haemoglobin&#xD;
             (HbA1c) of &gt; 59 mmol/mol (7.5%).&#xD;
&#xD;
          -  Use of systemic immunosuppressants within 30 days of dosing.&#xD;
&#xD;
          -  Currently receiving oral steroids, cytotoxic drugs (e.g., chlorambucil, azathioprine,&#xD;
             cyclophosphamide, methotrexate), antifibrotic drugs (e.g., pirfenidone), vasodilator&#xD;
             therapies for pulmonary hypertension (e.g., bosentan), unapproved (e.g., interferon&#xD;
             gamma (INF γ), penicillamine, cyclosporine, mycophenolate) and/or investigational&#xD;
             therapies for IPF or administration of such therapies within 4 weeks of initial&#xD;
             screening. A current inhaled steroid dose of ≤ 1000 µg beclomethasone dipropionate&#xD;
             equivalent per day was acceptable if the dose was anticipated to remain stable during&#xD;
             the study.&#xD;
&#xD;
          -  History of malignancy, including carcinoma during the preceding 5 years.&#xD;
&#xD;
          -  History of, or current asthma.&#xD;
&#xD;
          -  Participation in a clinical study of an unlicensed drug in the previous 4 months, or a&#xD;
             marketed drug study within the previous 3 months. (N.B. washout period between studies&#xD;
             defined as the period of time elapsed between the last dose of the previous study and&#xD;
             the first dose of the next study).&#xD;
&#xD;
          -  Females of child bearing potential and/or with a positive pregnancy test at the&#xD;
             screening visit.&#xD;
&#xD;
        Confirmed at Baseline / Prior to First Dose:&#xD;
&#xD;
        • Development of any exclusion criteria since the screening visit.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Toby Maher, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Royal Brompton &amp; Harefield NHS Foundation Trust</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Royal Devon &amp; Exeter Foundation NHS Trust</name>
      <address>
        <city>Exeter</city>
        <state>Devon</state>
        <zip>EX2 5DW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Edinburgh University Hospital</name>
      <address>
        <city>Edinburgh</city>
        <state>Scotland</state>
        <zip>EH16 4SA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Newcastle Upon Tyne Hospitals NHS Foundation Trust</name>
      <address>
        <city>Newcastle</city>
        <state>Tyne And Wear</state>
        <zip>NE3 3HD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Simbec Research Limited</name>
      <address>
        <city>Merthyr Tydfil</city>
        <state>Wales</state>
        <zip>CF48 4DR</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Brompton Hospital</name>
      <address>
        <city>London</city>
        <zip>SW3 6NP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>September 29, 2014</study_first_submitted>
  <study_first_submitted_qc>October 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 6, 2014</study_first_posted>
  <results_first_submitted>February 22, 2021</results_first_submitted>
  <results_first_submitted_qc>March 16, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">April 8, 2021</results_first_posted>
  <last_update_submitted>March 16, 2021</last_update_submitted>
  <last_update_submitted_qc>March 16, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pulmonary Fibrosis</mesh_term>
    <mesh_term>Idiopathic Pulmonary Fibrosis</mesh_term>
    <mesh_term>Fibrosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Interim data from the patient trial will be presented at ICLAF, Dublin 2016</ipd_description>
  </patient_data>
  <provided_document_section>
    <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>April 5, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/77/NCT02257177/Prot_000.pdf</document_url>
    </provided_document>
    <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>February 5, 2015</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/77/NCT02257177/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>A total of 60 subjects were randomised, 39 randomized to treatment, with 24 subjects in Part 1 and 15 subjects in Part 2.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>0.15 mg TD139 (Part 1)</title>
          <description>4 Healthy Subjects are administered a single dose of 0.15mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later.&#xD;
Inhaled TD139: DPI Galectin-3 inhibitor</description>
        </group>
        <group group_id="P2">
          <title>1.5 mg TD139 (Part 1)</title>
          <description>4 Healthy Subjects are administered a single dose of 1.5mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later.&#xD;
Inhaled TD139: DPI Galectin-3 inhibitor</description>
        </group>
        <group group_id="P3">
          <title>3 mg TD139 (Part 1)</title>
          <description>4 Healthy Subjects are administered a single dose of 3mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later.&#xD;
Inhaled TD139: DPI Galectin-3 inhibitor</description>
        </group>
        <group group_id="P4">
          <title>10 mg TD139 Part 1</title>
          <description>4 Healthy Subjects are administered a single dose of 10mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later.&#xD;
Inhaled TD139: DPI Galectin-3 inhibitor</description>
        </group>
        <group group_id="P5">
          <title>20 mg TD139 Part 1</title>
          <description>4 Healthy Subjects are administered a single dose of 20mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later.&#xD;
Inhaled TD139: DPI Galectin-3 inhibitor</description>
        </group>
        <group group_id="P6">
          <title>50 mg TD139 Part 1</title>
          <description>4 Healthy Subjects are administered a single dose of 50mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later.&#xD;
Inhaled TD139: DPI Galectin-3 inhibitor</description>
        </group>
        <group group_id="P7">
          <title>Placebo Part 1</title>
          <description>12 Healthy Subjects are administered placebo inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later.&#xD;
Placebo: DPI placebo</description>
        </group>
        <group group_id="P8">
          <title>0.3 mg TD139 Part 2</title>
          <description>5 Patients with IPF are administered a single dose of 0.3mg TD139 once daily for 14 days inhaled as a dry powder.</description>
        </group>
        <group group_id="P9">
          <title>3 mg TD139 Part 2</title>
          <description>5 Patients with IPF are administered a single dose of 3mg TD139 once daily for 14 days inhaled as a dry powder.</description>
        </group>
        <group group_id="P10">
          <title>10 mg TD139 Part 2</title>
          <description>5 Patients with IPF are administered a single dose of 10mg TD139 once daily for 14 days inhaled as a dry powder.</description>
        </group>
        <group group_id="P11">
          <title>Placebo Part 2</title>
          <description>9 Patients with IPF are administered placebo inhaled as a dry powder.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="4"/>
                <participants group_id="P5" count="4"/>
                <participants group_id="P6" count="4"/>
                <participants group_id="P7" count="12"/>
                <participants group_id="P8" count="5"/>
                <participants group_id="P9" count="5"/>
                <participants group_id="P10" count="5"/>
                <participants group_id="P11" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="4"/>
                <participants group_id="P5" count="4"/>
                <participants group_id="P6" count="4"/>
                <participants group_id="P7" count="12"/>
                <participants group_id="P8" count="5"/>
                <participants group_id="P9" count="5"/>
                <participants group_id="P10" count="4"/>
                <participants group_id="P11" count="9"/>
              </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="1"/>
                <participants group_id="P11" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>0.15 mg TD139 (Part 1)</title>
          <description>4 Healthy Subjects are administered a single dose of 0.15mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later.&#xD;
Inhaled TD139: DPI Galectin-3 inhibitor</description>
        </group>
        <group group_id="B2">
          <title>1.5 mg TD139 (Part 1)</title>
          <description>4 Healthy Subjects are administered a single dose of 1.5mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later.&#xD;
Inhaled TD139: DPI Galectin-3 inhibitor</description>
        </group>
        <group group_id="B3">
          <title>3 mg TD139 (Part 1)</title>
          <description>4 Healthy Subjects are administered a single dose of 3mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later.&#xD;
Inhaled TD139: DPI Galectin-3 inhibitor</description>
        </group>
        <group group_id="B4">
          <title>10 mg TD139 Part 1</title>
          <description>4 Healthy Subjects are administered a single dose of 10mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later.&#xD;
Inhaled TD139: DPI Galectin-3 inhibitor</description>
        </group>
        <group group_id="B5">
          <title>20 mg TD139 Part 1</title>
          <description>4 Healthy Subjects are administered a single dose of 20mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later.&#xD;
Inhaled TD139: DPI Galectin-3 inhibitor</description>
        </group>
        <group group_id="B6">
          <title>50 mg TD139 Part 1</title>
          <description>4 Healthy Subjects are administered a single dose of 50mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later.&#xD;
Inhaled TD139: DPI Galectin-3 inhibitor</description>
        </group>
        <group group_id="B7">
          <title>Placebo Part 1</title>
          <description>12 Healthy Subjects are administered placebo inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later.&#xD;
Placebo: DPI placebo</description>
        </group>
        <group group_id="B8">
          <title>0.3 mg TD139 Part 2</title>
          <description>5 Patients with IPF are administered a single dose of 0.3mg TD139 once daily for 14 days inhaled as a dry powder.</description>
        </group>
        <group group_id="B9">
          <title>3 mg TD139 Part 2</title>
          <description>5 Patients with IPF are administered a single dose of 3mg TD139 once daily for 14 days inhaled as a dry powder.</description>
        </group>
        <group group_id="B10">
          <title>10 mg TD139 Part 2</title>
          <description>5 Patients with IPF are administered a single dose of 10mg TD139 once daily for 14 days inhaled as a dry powder.</description>
        </group>
        <group group_id="B11">
          <title>Placebo Part 2</title>
          <description>9 Patients with IPF are administered placebo inhaled as a dry powder.</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="4"/>
            <count group_id="B2" value="4"/>
            <count group_id="B3" value="4"/>
            <count group_id="B4" value="4"/>
            <count group_id="B5" value="4"/>
            <count group_id="B6" value="4"/>
            <count group_id="B7" value="12"/>
            <count group_id="B8" value="5"/>
            <count group_id="B9" value="5"/>
            <count group_id="B10" value="5"/>
            <count group_id="B11" value="9"/>
            <count group_id="B12" value="60"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</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>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="4"/>
                    <measurement group_id="B6" value="4"/>
                    <measurement group_id="B7" value="12"/>
                    <measurement group_id="B8" value="1"/>
                    <measurement group_id="B9" value="1"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" value="38"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</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="4"/>
                    <measurement group_id="B9" value="4"/>
                    <measurement group_id="B10" value="5"/>
                    <measurement group_id="B11" value="9"/>
                    <measurement group_id="B12" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <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="42.3" spread="9.07"/>
                    <measurement group_id="B2" value="29.8" spread="6.80"/>
                    <measurement group_id="B3" value="39.3" spread="10.21"/>
                    <measurement group_id="B4" value="29.8" spread="2.06"/>
                    <measurement group_id="B5" value="30.8" spread="9.54"/>
                    <measurement group_id="B6" value="32.8" spread="9.91"/>
                    <measurement group_id="B7" value="35.6" spread="7.53"/>
                    <measurement group_id="B8" value="69.0" spread="6.32"/>
                    <measurement group_id="B9" value="73.6" spread="5.86"/>
                    <measurement group_id="B10" value="79.2" spread="2.77"/>
                    <measurement group_id="B11" value="72.9" spread="4.59"/>
                    <measurement group_id="B12" value="50.2" spread="20.63"/>
                  </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="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="1"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="4"/>
                    <measurement group_id="B6" value="4"/>
                    <measurement group_id="B7" value="12"/>
                    <measurement group_id="B8" value="4"/>
                    <measurement group_id="B9" value="5"/>
                    <measurement group_id="B10" value="5"/>
                    <measurement group_id="B11" value="9"/>
                    <measurement group_id="B12" value="59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United Kingdom</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="4"/>
                    <measurement group_id="B6" value="4"/>
                    <measurement group_id="B7" value="12"/>
                    <measurement group_id="B8" value="5"/>
                    <measurement group_id="B9" value="5"/>
                    <measurement group_id="B10" value="5"/>
                    <measurement group_id="B11" value="9"/>
                    <measurement group_id="B12" value="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Adverse Events</title>
        <description>Number of participants reporting Adverse Events from the date of first dose, until 30 days post first dose.</description>
        <time_frame>0 - 30 days</time_frame>
        <population>All subjects in Part 1 are included in the safety population. The safety population includes all subjects who received at least one dose of study treatment (TD139 or Placebo). Safety parameters are listed and summarised using descriptive statistics. No formal statistical analysis is planned.</population>
        <group_list>
          <group group_id="O1">
            <title>0.15 mg TD139 (Part 1)</title>
            <description>4 Healthy Subjects are administered a single dose of 0.15mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later.&#xD;
Inhaled TD139: DPI Galectin-3 inhibitor</description>
          </group>
          <group group_id="O2">
            <title>1.5 mg TD139 (Part 1)</title>
            <description>4 Healthy Subjects are administered a single dose of 1.5mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later.&#xD;
Inhaled TD139: DPI Galectin-3 inhibitor</description>
          </group>
          <group group_id="O3">
            <title>3 mg TD139 (Part 1)</title>
            <description>4 Healthy Subjects are administered a single dose of 3mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later.&#xD;
Inhaled TD139: DPI Galectin-3 inhibitor</description>
          </group>
          <group group_id="O4">
            <title>10 mg TD139 Part 1</title>
            <description>4 Healthy Subjects are administered a single dose of 10mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later.&#xD;
Inhaled TD139: DPI Galectin-3 inhibitor</description>
          </group>
          <group group_id="O5">
            <title>20 mg TD139 Part 1</title>
            <description>4 Healthy Subjects are administered a single dose of 20mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later.&#xD;
Inhaled TD139: DPI Galectin-3 inhibitor</description>
          </group>
          <group group_id="O6">
            <title>50 mg TD139 Part 1</title>
            <description>4 Healthy Subjects are administered a single dose of 50mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later.&#xD;
Inhaled TD139: DPI Galectin-3 inhibitor</description>
          </group>
          <group group_id="O7">
            <title>Placebo Part 1</title>
            <description>12 Healthy Subjects are administered placebo inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later.&#xD;
Placebo: DPI placebo</description>
          </group>
          <group group_id="O8">
            <title>0.3 mg TD139 Part 2</title>
            <description>5 Patients with IPF are administered a single dose of 0.3mg TD139 once daily for 14 days inhaled as a dry powder.</description>
          </group>
          <group group_id="O9">
            <title>3 mg TD139 Part 2</title>
            <description>5 Patients with IPF are administered a single dose of 3mg TD139 once daily for 14 days inhaled as a dry powder.</description>
          </group>
          <group group_id="O10">
            <title>10 mg TD139 Part 2</title>
            <description>5 Patients with IPF are administered a single dose of 10mg TD139 once daily for 14 days inhaled as a dry powder.</description>
          </group>
          <group group_id="O11">
            <title>Placebo Part 2</title>
            <description>9 Patients with IPF are administered placebo inhaled as a dry powder.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Adverse Events</title>
          <description>Number of participants reporting Adverse Events from the date of first dose, until 30 days post first dose.</description>
          <population>All subjects in Part 1 are included in the safety population. The safety population includes all subjects who received at least one dose of study treatment (TD139 or Placebo). Safety parameters are listed and summarised using descriptive statistics. No formal statistical analysis is planned.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="4"/>
                <count group_id="O3" value="4"/>
                <count group_id="O4" value="4"/>
                <count group_id="O5" value="4"/>
                <count group_id="O6" value="4"/>
                <count group_id="O7" value="12"/>
                <count group_id="O8" value="5"/>
                <count group_id="O9" value="5"/>
                <count group_id="O10" value="5"/>
                <count group_id="O11" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="4"/>
                    <measurement group_id="O6" value="4"/>
                    <measurement group_id="O7" value="2"/>
                    <measurement group_id="O8" value="4"/>
                    <measurement group_id="O9" value="5"/>
                    <measurement group_id="O10" value="4"/>
                    <measurement group_id="O11" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse Events are measured from the administration of the first dose, until 30 days post first dose</time_frame>
      <group_list>
        <group group_id="E1">
          <title>0.15 mg TD139 (Part 1)</title>
          <description>4 Healthy Subjects are administered a single dose of 0.15mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later.&#xD;
Inhaled TD139: DPI Galectin-3 inhibitor</description>
        </group>
        <group group_id="E2">
          <title>1.5 mg TD139 (Part 1)</title>
          <description>4 Healthy Subjects are administered a single dose of 1.5mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later.&#xD;
Inhaled TD139: DPI Galectin-3 inhibitor</description>
        </group>
        <group group_id="E3">
          <title>3 mg TD139 (Part 1)</title>
          <description>4 Healthy Subjects are administered a single dose of 3mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later.&#xD;
Inhaled TD139: DPI Galectin-3 inhibitor</description>
        </group>
        <group group_id="E4">
          <title>10 mg TD139 Part 1</title>
          <description>4 Healthy Subjects are administered a single dose of 10mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later.&#xD;
Inhaled TD139: DPI Galectin-3 inhibitor</description>
        </group>
        <group group_id="E5">
          <title>20 mg TD139 Part 1</title>
          <description>4 Healthy Subjects are administered a single dose of 20mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later.&#xD;
Inhaled TD139: DPI Galectin-3 inhibitor</description>
        </group>
        <group group_id="E6">
          <title>50 mg TD139 Part 1</title>
          <description>4 Healthy Subjects are administered a single dose of 50mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later.&#xD;
Inhaled TD139: DPI Galectin-3 inhibitor</description>
        </group>
        <group group_id="E7">
          <title>Placebo Part 1</title>
          <description>12 Healthy Subjects are administered placebo inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later.&#xD;
Placebo: DPI placebo</description>
        </group>
        <group group_id="E8">
          <title>0.3 mg TD139 Part 2</title>
          <description>5 Patients with IPF are administered a single dose of 0.3mg TD139 once daily for 14 days inhaled as a dry powder.</description>
        </group>
        <group group_id="E9">
          <title>3 mg TD139 Part 2</title>
          <description>5 Patients with IPF are administered a single dose of 3mg TD139 once daily for 14 days inhaled as a dry powder.</description>
        </group>
        <group group_id="E10">
          <title>10 mg TD139 Part 2</title>
          <description>5 Patients with IPF are administered a single dose of 10mg TD139 once daily for 14 days inhaled as a dry powder.</description>
        </group>
        <group group_id="E11">
          <title>Placebo Part 2</title>
          <description>9 Patients with IPF are administered placebo inhaled as a dry powder.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 17.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <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="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA 17.0</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="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="12"/>
                <counts group_id="E8" subjects_affected="4" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="5" subjects_at_risk="5"/>
                <counts group_id="E10" subjects_affected="4" subjects_at_risk="5"/>
                <counts group_id="E11" subjects_affected="7" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Adrenal Suppression</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal Pain Upper</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E9" events="2" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E11" events="2" subjects_affected="1" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E10" events="3" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Vessel Puncture Site Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Upper Respiratory Tract Infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Ear Infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Localised Infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Lower Respiratory Tract Infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Urinary Tract Infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="9"/>
              </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" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Flank Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Gout</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Musculoskeletal Discomfort</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="4"/>
                <counts group_id="E5" events="4" subjects_affected="4" subjects_at_risk="4"/>
                <counts group_id="E6" events="4" subjects_affected="4" subjects_at_risk="4"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="4"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="3" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E11" events="2" subjects_affected="2" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Sinus Headache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Bladder and Urethral Symptoms</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Urinary Retention</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="2" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Wheezing</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E11" events="2" subjects_affected="1" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Oropharyngeal Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Upper-airway Cough Syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Actinic Keratosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Rosacea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Seborrheic dermatitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="9"/>
              </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>The Investigators must agree to maintain the confidentiality of the study at all times and must not reveal any information relating to the study without express permission from the study Sponsor.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Professor Bertil Lindmark</name_or_title>
      <organization>Galecto</organization>
      <phone>+4570705210</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/NCT02257177
org study id: GB-HV-01
nct id: NCT02257177
lead sponsor: 
has dmc: Yes
This study will be divided into 2 parts. Part 1 is a randomized, double-blind, single centre,
      placebo-controlled, single ascending dose (SAD) phase I study designed to assess the safety,
      tolerability, PK and PD (Pharmacodynamic) of TD139 in up to 36 healthy male subjects. Part 2
      will be a randomized, double-blind, multi-centre, placebo-controlled, multiple dose expansion
      cohort, designed to assess the safety, tolerability, PK and PD of TD139 in up to 24 male
      subjects and female subjects of non child-bearing potential with IPF.
Up to 6 cohorts of 6 subjects will be randomly assigned in a blinded fashion to receive
      either a single dose of TD139 or matching placebo via DPI (dry powder inhaler) in an
      ascending dose fashion.

      A single cohort of up to 24 patients will be randomly assigned in a blinded fashion to
      receive a single dose of TD139 or placebo via DPI once daily for 14 days in a 2:1 TD139 to
      placebo ratio. The dose of TD139 selected will be based on data from Part 1 and on
      pre-clinical efficacy and safety data.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Number of Participants With Adverse Events
time frame: 0 - 30 days
description: Number of participants reporting Adverse Events from the date of first dose, until 30 days post first dose.
arm group label: 0.15 mg TD139 (Part 1)
arm group type: Active Comparator
description: 4 Healthy Subjects are administered a single dose of 0.15mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later.
arm group label: 1.5 mg TD139 (Part 1)
arm group type: Active Comparator
description: 4 Healthy Subjects are administered a single dose of 1.5mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later.
arm group label: 3 mg TD139 (Part 1)
arm group type: Active Comparator
description: 4 Healthy Subjects are administered a single dose of 3mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later.
arm group label: 10 mg TD139 Part 1
arm group type: Active Comparator
description: 4 Healthy Subjects are administered a single dose of 10mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later.
arm group label: 20 mg TD139 Part 1
arm group type: Active Comparator
description: 4 Healthy Subjects are administered a single dose of 20mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later.
arm group label: 50 mg TD139 Part 1
arm group type: Active Comparator
description: 4 Healthy Subjects are administered a single dose of 50mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later.
arm group label: Placebo Part 1
arm group type: Placebo Comparator
description: 12 Healthy Subjects are administered placebo inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later.
arm group label: 0.3 mg TD139 Part 2
arm group type: Active Comparator
description: 5 Patients with IPF are administered a single dose of 0.3mg TD139 once daily for 14 days inhaled as a dry powder.
arm group label: 3 mg TD139 Part 2
arm group type: Active Comparator
description: 5 Patients with IPF are administered a single dose of 3mg TD139 once daily for 14 days inhaled as a dry powder.
arm group label: 10 mg TD139 Part 2
arm group type: Active Comparator
description: 5 Patients with IPF are administered a single dose of 10mg TD139 once daily for 14 days inhaled as a dry powder.
arm group label: Placebo Part 2
arm group type: Placebo Comparator
description: 9 Patients with IPF are administered placebo inhaled as a dry powder.
intervention type: Drug
intervention name: Inhaled TD139
description: DPI Galectin-3 inhibitor
arm group label: 0.15 mg TD139 (Part 1)
arm group label: 0.3 mg TD139 Part 2
arm group label: 1.5 mg TD139 (Part 1)
arm group label: 10 mg TD139 Part 1
arm group label: 10 mg TD139 Part 2
arm group label: 20 mg TD139 Part 1
arm group label: 3 mg TD139 (Part 1)
arm group label: 3 mg TD139 Part 2
arm group label: 50 mg TD139 Part 1
other name: TD139
intervention type: Drug
intervention name: Placebo
description: DPI placebo
arm group label: Placebo Part 1
arm group label: Placebo Part 2
other name: inhaled placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Toby Maher, MD
role: Principal Investigator
affiliation: Royal Brompton & Harefield NHS Foundation Trust
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country: United Kingdom
responsible party type: Sponsor
mesh term: Pulmonary Fibrosis
mesh term: Idiopathic Pulmonary Fibrosis
mesh term: Fibrosis
sharing ipd: Yes
ipd description: Interim data from the patient trial will be presented at ICLAF, Dublin 2016
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