xml: <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/NCT05975047</url>
    </required_header>
    <id_info>
      <org_study_id>LIV001-01</org_study_id>
      <nct_id>NCT05975047</nct_id>
    </id_info>
    <brief_title>A Study of LIV001 in Healthy Subjects and Those With Mild-to-Moderate Active Ulcerative Colitis (UC)</brief_title>
    <official_title>A Phase 1a/1b Randomized, Double-Blind, Placebo-Controlled Study of Single and Multiple Ascending Doses of LIV001 in Healthy Subjects and Multiple Doses of LIV001 in Subjects With Mild-to-Moderate Active Ulcerative Colitis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Liveome Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Liveome Inc.</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study is only for the first in human phase 1a study designed to investigate the safety&#xD;
        and tolerability of LIV001 in healthy participants. LIV001 will be investigated for the&#xD;
        safety and efficacy in participants with Ulcerative Colitis (UC) in a phase 1b study.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The study will be conducted in 2 parts. Approximately 36 subjects are planned to be enrolled&#xD;
        into the study.&#xD;
  &#xD;
          -  In Part A (SAD), approximately 18 healthy subjects will be enrolled in 2 sequential&#xD;
             cohorts (Cohorts SAD1 and SAD2) and randomized 2:1 to receive a single dose of&#xD;
             investigational product (IP) (LIV001 or placebo)&#xD;
  &#xD;
          -  In Part B (MAD), approximately 18 healthy subjects will be enrolled into 2 sequential&#xD;
             cohorts (Cohorts MAD1 and MAD2) and randomized 2:1 to receive LIV001 or placebo for 14&#xD;
             days.&#xD;
  &#xD;
        Oversight of the study will be provided by a Safety review committee (SRC) comprising the&#xD;
        Principal Investigator (PI), the local Medical Monitor (MM), and a representative of the&#xD;
        Sponsor, at a minimum.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 13, 2023</start_date>
    <completion_date type="Anticipated">July 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">May 29, 2024</primary_completion_date>
    <phase>Phase 1</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Sequential Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Number of participants with adverse events (AEs)</measure>
      <time_frame>Upto 14 days from Part A; Upto 28 days for Part B</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of participants with clinical laboratory abnormalities</measure>
      <time_frame>Upto 14 days from Part A; Upto 28 days for Part B</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of participants with changes in the 12-lead electrocardiogram (ECG)</measure>
      <time_frame>Upto 14 days from Part A; Upto 28 days for Part B</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of participants with changes in stools as self assessed through Bristol stool form scale (BSFS)</measure>
      <time_frame>Upto 14 days from Part A; Upto 28 days for Part B</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Number of participants detected tection of LIV001 in stool samples by quantitative polymerase chain reaction (qPCR)</measure>
      <time_frame>Upto 14 days from Part A; Upto 28 days for Part B</time_frame>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">36</enrollment>
    <condition>Ulcerative Colitis</condition>
    <arm_group>
      <arm_group_label>LIV001</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Drug: LIV001&#xD;
  Dosage level:&#xD;
  Part A will receive single dose of either one or 10 capsules of 280 mg capsule of IP or placebo on Day 1; Part B participants will receive multiple doses of 280 mg capsule of IP or placebo from Day 1 to Day 14 after overnight fast ;&#xD;
  Dosage form- capsule&#xD;
  Route of administration- Oral</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Placebo comparator taken by participants randomized to the placebo arm across Part A, B and C of the study.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>LIV001</intervention_name>
      <description>Part A- Participants will receive single dose of 280mg capsule on day 1 under fasting conditions; Part B- Participants will receive multiple doses of 280mg capsule from day 1 to day 14 under fasting conditions;</description>
      <arm_group_label>LIV001</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Participants will receive matching placebo across Part A and B of the study</description>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Part A (SAD) and Part B (MAD)&#xD;
  &#xD;
            1. Male or female, aged 18 to 60 years (inclusive) at Screening.&#xD;
  &#xD;
            2. Body mass index (BMI) 18 kg/m2 to ≤ 32 kg/m2 (inclusive) at Screening.&#xD;
  &#xD;
            3. Subject is generally healthy, in the opinion of the Investigator, based on assessment&#xD;
               of medical history, physical examination, vital signs, ECG, laboratory parameters, and&#xD;
               other relevant tests conducted at Screening.&#xD;
  &#xD;
            4. Subject has clinical laboratory values within normal range, as specified by the&#xD;
               testing laboratory, at Screening and Day 1, unless deemed not clinically significant&#xD;
               by the Investigator or delegate.&#xD;
  &#xD;
            5. Nonsmoker or casual smoker who agrees to smoke ≤ 5 cigarettes per week (includes&#xD;
               e-cigarettes and other nicotine and tobacco products) during the study, including&#xD;
               follow-up, and is willing to abstain from smoking/nicotine products during the CTU&#xD;
               confinement period(s) and for ≥ 5 days before each study visit.&#xD;
  &#xD;
            6. Male and female must agree to contraceptive usage as per protocol from Screening&#xD;
               through 90 days after final dose of IP.&#xD;
  &#xD;
            7. Willing and able to comply with all study-related procedures and assessments,&#xD;
               including attending visits to the CTU.&#xD;
  &#xD;
            8. Able to read and understand, and willing to sign the ICF.&#xD;
  &#xD;
            9. Willing to allow storage of blood and fecal samples for future studies of genetic&#xD;
               make-up.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Part A (SAD) and Part B (MAD)&#xD;
  &#xD;
            1. Female subjects who are pregnant or lactating.&#xD;
  &#xD;
            2. Abnormal ECG findings at Screening or Day -1 that are considered by the Investigator&#xD;
               or designee to be clinically significant.&#xD;
  &#xD;
            3. Has taken prescription medication (including antibiotics) within 14 days or&#xD;
               over-the-counter (OTC) non-prescription medication, herbal remedies, vitamins or&#xD;
               minerals, probiotics (foods containing probiotics are permitted), and yeast&#xD;
               supplements (eg, Mutaflor®, Bioflor®) within 7 days prior to the first dose of IP that&#xD;
               may, in the opinion of the Investigator, compromise subject safety or interfere with&#xD;
               study procedures or data validity. Subjects may be rescreened after a washout period&#xD;
               of 14 days for prescription medication or 7 days for OTC products. Use of oral&#xD;
               contraceptives and paracetamol (1 to 2 therapeutic doses per week, ie, up to 2 g per&#xD;
               week) and/or nonsteroidal anti-inflammatory drugs for symptomatic relief of minor&#xD;
               symptoms is permitted.&#xD;
  &#xD;
            4. Functional gastrointestinal disorders, eg, irritable bowel syndrome, functional&#xD;
               heartburn, functional nausea, functional dyspepsia, functional constipation, and&#xD;
               functional diarrhea.&#xD;
  &#xD;
            5. Substance abuse-related disorder or a history of drug, alcohol (ie, regular use of &gt;&#xD;
               21 units of alcohol per week) and/or substance abuse deemed significant by the&#xD;
               Investigator.&#xD;
  &#xD;
            6. Has taken any IP or received IP in another clinical trial within 30 days prior to the&#xD;
               first dose of IP or 5 half-lives, whichever is longer.&#xD;
  &#xD;
            7. History of significant hypersensitivity or severe allergic or anaphylactic reactions&#xD;
               involving any drug (including ampicillin, clindamycin or imipenem), any constituent of&#xD;
               the IP (LIV001 or its excipients), food or other precipitating agent (eg, bee sting).&#xD;
               Subjects with clinically stable mild allergic conditions such as hay fever and mild&#xD;
               eczema may be enrolled at the discretion of the Investigator.&#xD;
  &#xD;
            8. Positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen&#xD;
               (HBsAg), or hepatitis C virus antibody (anti-HCV) at Screening.&#xD;
  &#xD;
            9. Positive screen for drugs of abuse at Screening or Day -1, or positive screen for&#xD;
               alcohol on Day -1.&#xD;
  &#xD;
           10. Subject is, in the opinion of the Investigator, unlikely to comply with the clinical&#xD;
               study protocol or is unsuitable for any other reason.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Sophie Hyun-Ja-Ko</last_name>
      <phone>+82-31-8065-8216</phone>
      <email>sophieko@liveome.co.kr</email>
    </overall_contact>
    <location>
      <facility>
        <name>Nucleus Network Pty Ltd</name>
        <address>
          <city>Melbourne</city>
          <state>Victoria</state>
          <zip>3004</zip>
          <country>Australia</country>
        </address>
      </facility>
      <contact>
        <last_name>Christina Chang, Dr</last_name>
      </contact>
    </location>
    <location_countries>
      <country>Australia</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 26, 2023</study_first_submitted>
    <study_first_submitted_qc>July 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 3, 2023</study_first_posted>
    <last_update_submitted>July 26, 2023</last_update_submitted>
    <last_update_submitted_qc>July 26, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 3, 2023</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>Colitis</mesh_term>
      <mesh_term>Colitis, Ulcerative</mesh_term>
      <mesh_term>Ulcer</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05975047
  org study id: LIV001-01
  nct id: NCT05975047
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  This study is only for the first in human phase 1a study designed to investigate the safety
        and tolerability of LIV001 in healthy participants. LIV001 will be investigated for the
        safety and efficacy in participants with Ulcerative Colitis (UC) in a phase 1b study.
  The study will be conducted in 2 parts. Approximately 36 subjects are planned to be enrolled
        into the study.
  
          -  In Part A (SAD), approximately 18 healthy subjects will be enrolled in 2 sequential
             cohorts (Cohorts SAD1 and SAD2) and randomized 2:1 to receive a single dose of
             investigational product (IP) (LIV001 or placebo)
  
          -  In Part B (MAD), approximately 18 healthy subjects will be enrolled into 2 sequential
             cohorts (Cohorts MAD1 and MAD2) and randomized 2:1 to receive LIV001 or placebo for 14
             days.
  
        Oversight of the study will be provided by a Safety review committee (SRC) comprising the
        Principal Investigator (PI), the local Medical Monitor (MM), and a representative of the
        Sponsor, at a minimum.
  allocation: Randomized
  intervention model: Sequential Assignment
  primary purpose: Treatment
  masking: Triple (Participant, Investigator, Outcomes Assessor)
  measure: Number of participants with adverse events (AEs)
  time frame: Upto 14 days from Part A; Upto 28 days for Part B
  measure: Number of participants with clinical laboratory abnormalities
  time frame: Upto 14 days from Part A; Upto 28 days for Part B
  measure: Number of participants with changes in the 12-lead electrocardiogram (ECG)
  time frame: Upto 14 days from Part A; Upto 28 days for Part B
  measure: Number of participants with changes in stools as self assessed through Bristol stool form scale (BSFS)
  time frame: Upto 14 days from Part A; Upto 28 days for Part B
  measure: Number of participants detected tection of LIV001 in stool samples by quantitative polymerase chain reaction (qPCR)
  time frame: Upto 14 days from Part A; Upto 28 days for Part B
  arm group label: LIV001
  arm group type: Experimental
  description: Drug: LIV001
  Dosage level:
  Part A will receive single dose of either one or 10 capsules of 280 mg capsule of IP or placebo on Day 1; Part B participants will receive multiple doses of 280 mg capsule of IP or placebo from Day 1 to Day 14 after overnight fast ;
  Dosage form- capsule
  Route of administration- Oral
  arm group label: Placebo
  arm group type: Placebo Comparator
  description: Placebo comparator taken by participants randomized to the placebo arm across Part A, B and C of the study.
  intervention type: Drug
  intervention name: LIV001
  description: Part A- Participants will receive single dose of 280mg capsule on day 1 under fasting conditions; Part B- Participants will receive multiple doses of 280mg capsule from day 1 to day 14 under fasting conditions;
  arm group label: LIV001
  intervention type: Drug
  intervention name: Placebo
  description: Participants will receive matching placebo across Part A and B of the study
  arm group label: Placebo
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 60 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Sophie Hyun-Ja-Ko
  phone: +82-31-8065-8216
  email: sophieko@liveome.co.kr
  facility: 
  contact: 
  country: Australia
  responsible party type: Sponsor
  mesh term: Colitis
  mesh term: Colitis, Ulcerative
  mesh term: Ulcer
  sharing ipd: No