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/NCT06026397</url>
    </required_header>
    <id_info>
      <org_study_id>SK10-101</org_study_id>
      <nct_id>NCT06026397</nct_id>
    </id_info>
    <brief_title>A Sequential Single and Multiple Ascending Dose (SAD/MAD) Study of SK10 Powders in Healthy Adult Subjects</brief_title>
    <official_title>A Randomized, Double-blind, Placebo-controlled, Sequential Dose-escalation Clinical Study to Evaluate the Safety and Tolerability of SK10 Powders (Inactivated Bacteroides Fragilis) in Healthy Adult Subjects</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Guangzhou Zhiyi Biotechnology Co., Ltd.</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Guangzhou Zhiyi Biotechnology Co., Ltd.</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this study is to assess the safety and tolerability of orally administered&#xD;
        SK10 powders in healthy adult subjects at three dose levels, following single and multiple&#xD;
        doses.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a first-in-human, Phase 1, randomized, double-blind, placebo-controlled, sequential&#xD;
        SAD and MAD study to assess the safety and tolerability of orally administered SK10 powders&#xD;
        in healthy adult subjects.&#xD;
  &#xD;
        This is a dose escalation study with three sequential cohorts planned testing at 3 dose&#xD;
        levels.&#xD;
  &#xD;
        A total of 24 subjects are planned to be enrolled into 3 cohorts (Cohorts 1, 2 and 3). Within&#xD;
        each cohort, eligible subjects will be randomized to receive SK10 or placebo in a 3:1 ratio.&#xD;
        The treatment duration includes a single dose administration on Day 1 and 14-day repeat doses&#xD;
        administration from Day 4 to Day 17.&#xD;
  &#xD;
        The study consists of:&#xD;
  &#xD;
          -  Screening Period (28 days [Day -28 to Day -1])&#xD;
  &#xD;
          -  Treatment Period (Day -1 to Day 19)&#xD;
  &#xD;
          -  Follow-up Visit (Day 24).&#xD;
  &#xD;
        The study duration will be approximately up to 52 days, conducted at a single center.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 22, 2023</start_date>
    <completion_date type="Anticipated">January 20, 2024</completion_date>
    <primary_completion_date type="Anticipated">January 20, 2024</primary_completion_date>
    <phase>Phase 1</phase>
    <study_type>Interventional</study_type>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Sequential 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 Treatment-Emergent Adverse Events (TEAEs)</measure>
      <time_frame>From screening (Day -28) up to follow-up [FU] (Days 24±2)</time_frame>
      <description>Number of participants with TEAEs to evaluate the safety and tolerability of SK10 in healthy adult subjects</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of participants with clinically relevant changes from baseline electrocardiogram (ECG) parameters</measure>
      <time_frame>From screening (Day -28), Days -1,1,3, 11,19 up to FU (Days 24±2)</time_frame>
      <description>Number of participants with clinically relevant changes from baseline ECG parameters to evaluate the safety and tolerability of SK10 in healthy adult subjects</description>
    </primary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">24</enrollment>
    <condition>Chemotherapy-induced Diarrhea</condition>
    <arm_group>
      <arm_group_label>Cohort 1</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive dose A of SK10 (n=6) or placebo (n=2)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Cohort 2</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive dose B of SK10 (n=6) or placebo (n=2)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Cohort 3</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive dose C of SK10 (n=6) or placebo (n=2)</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>SK10</intervention_name>
      <description>Participants will be randomized to receive oral suspension of SK10 powder, includes SAD on Day 1 and 14-days MAD from Day 4 to Day 17.</description>
      <arm_group_label>Cohort 1</arm_group_label>
      <arm_group_label>Cohort 2</arm_group_label>
      <arm_group_label>Cohort 3</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Participants will be randomized to receive oral suspension of placebo, includes SAD on Day 1 and 14-days MAD from Day 4 to Day 17.</description>
      <arm_group_label>Cohort 1</arm_group_label>
      <arm_group_label>Cohort 2</arm_group_label>
      <arm_group_label>Cohort 3</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Subject must have negative test results for hepatitis B surface antigen (HBsAg),&#xD;
               hepatitis B core antibody (HBcAb), anti-hepatitis C virus antibodies (anti-HCV) and&#xD;
               anti-human immunodeficiency virus (HIV) antibodies at Screening Visit&#xD;
  &#xD;
            -  Body weight ≥ 50.0 kg for males, or ≥ 45.0 kg for females, and body mass index within&#xD;
               the range of 18.0-28.0 kg/m2 (inclusive).&#xD;
  &#xD;
            -  A male subject must agree to use together with his female partner/ spouse a highly&#xD;
               effective contraception form of birth control in combination with a barrier method&#xD;
               throughout the clinical study period and until 90 days after the last dose of IMP.&#xD;
               Male subjects must also refrain from donating sperm from the time of informed consent&#xD;
               until 90 days after the last dose of IMP.&#xD;
  &#xD;
            -  A female subject is eligible to participate if she is not pregnant, not breastfeeding,&#xD;
               and at least one of the following conditions applies:&#xD;
  &#xD;
                 -  Non-childbearing potential (OR)&#xD;
  &#xD;
                 -  A woman of childbearing potential (WOCBP) who agrees to use highly effective&#xD;
                    methods of birth control in combination with a barrier method at least 3 months&#xD;
                    prior to the Screening Visit until 30 days after the last dose of IMP.&#xD;
  &#xD;
                 -  WOCBP must agree not to donate ova from the time of informed consent until 30&#xD;
                    days after the last dose of IMP.&#xD;
  &#xD;
                 -  WOCBP must have a negative serum pregnancy test at the Screening Visit.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  History or presence of clinically significant hematological, renal, endocrine,&#xD;
               pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or&#xD;
               allergic disease.&#xD;
  &#xD;
            -  History/current symptom related to gastrointestinal abnormalities within 2 weeks&#xD;
               before the first dose.&#xD;
  &#xD;
            -  Subject is a pregnant or lactating women.&#xD;
  &#xD;
            -  Known or suspected hypersensitivity to the IMP or excipients of the IMP.&#xD;
  &#xD;
            -  Subjects with lactose intolerance/allergy.&#xD;
  &#xD;
            -  Known or ongoing psychiatric disorders, or active neuropsychiatric disease deemed&#xD;
               clinically significant in the opinion of the investigator.&#xD;
  &#xD;
            -  Subject has used over-the-counter or other oral medications (excluding vitamins),&#xD;
               prescription medications, or herbal remedies within 14 days before dosing.&#xD;
  &#xD;
            -  Subject has had major surgery within 3 months before Screening, or plan to perform&#xD;
               surgery during the study.&#xD;
  &#xD;
            -  Subject experiences an acute medical condition or uses concomitant medication during&#xD;
               the Screening period.&#xD;
  &#xD;
            -  Subject has been treated with an investigational drug within 30 days or 5 half-lives&#xD;
               (whichever is longer) preceding the first dose of the IMP.&#xD;
  &#xD;
            -  Subject has taken probiotic foods and/or drinks and/or health products within 1 week&#xD;
               before the first dose.&#xD;
  &#xD;
            -  History of alcohol and/or illicit drug abuse within 2 years before Screening.&#xD;
  &#xD;
            -  Subject has positive urine drug or alcohol test at the Screening Visit or Admission.&#xD;
  &#xD;
            -  No more than 5 cigarettes are allowed from screening to admission, and smoking is not&#xD;
               allowed from admission until after the last follow-up visit.&#xD;
  &#xD;
            -  Subject has donated or lost ≥ 400 mL of whole blood within 3 months or donated plasma&#xD;
               within 14 days before Screening.&#xD;
  &#xD;
            -  Subjects has received vaccination within 14 days before the first dose or vaccination&#xD;
               planned during the study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>55 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Early Phase Clinical Unit (EPCU) - PAREXEL</name>
        <address>
          <city>Glendale</city>
          <state>California</state>
          <zip>91206</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>David Han, MD</last_name>
        <phone>818-254-1600</phone>
        <email>david.han@cctrials.com</email>
      </contact>
      <contact_backup>
        <last_name>Kea Agustin</last_name>
        <phone>562-410-2214</phone>
        <email>Kea.Agustin@parexel.com</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 30, 2023</study_first_submitted>
    <study_first_submitted_qc>August 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 7, 2023</study_first_posted>
    <last_update_submitted>August 30, 2023</last_update_submitted>
    <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Single ascending dose</keyword>
    <keyword>Multiple ascending dose</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Diarrhea</mesh_term>
    </condition_browse>
    <!-- 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/NCT06026397
  org study id: SK10-101
  nct id: NCT06026397
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  The purpose of this study is to assess the safety and tolerability of orally administered
        SK10 powders in healthy adult subjects at three dose levels, following single and multiple
        doses.
  This is a first-in-human, Phase 1, randomized, double-blind, placebo-controlled, sequential
        SAD and MAD study to assess the safety and tolerability of orally administered SK10 powders
        in healthy adult subjects.
  
        This is a dose escalation study with three sequential cohorts planned testing at 3 dose
        levels.
  
        A total of 24 subjects are planned to be enrolled into 3 cohorts (Cohorts 1, 2 and 3). Within
        each cohort, eligible subjects will be randomized to receive SK10 or placebo in a 3:1 ratio.
        The treatment duration includes a single dose administration on Day 1 and 14-day repeat doses
        administration from Day 4 to Day 17.
  
        The study consists of:
  
          -  Screening Period (28 days [Day -28 to Day -1])
  
          -  Treatment Period (Day -1 to Day 19)
  
          -  Follow-up Visit (Day 24).
  
        The study duration will be approximately up to 52 days, conducted at a single center.
  allocation: Randomized
  intervention model: Sequential Assignment
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Number of participants with Treatment-Emergent Adverse Events (TEAEs)
  time frame: From screening (Day -28) up to follow-up [FU] (Days 24±2)
  description: Number of participants with TEAEs to evaluate the safety and tolerability of SK10 in healthy adult subjects
  measure: Number of participants with clinically relevant changes from baseline electrocardiogram (ECG) parameters
  time frame: From screening (Day -28), Days -1,1,3, 11,19 up to FU (Days 24±2)
  description: Number of participants with clinically relevant changes from baseline ECG parameters to evaluate the safety and tolerability of SK10 in healthy adult subjects
  arm group label: Cohort 1
  arm group type: Experimental
  description: Participants will receive dose A of SK10 (n=6) or placebo (n=2)
  arm group label: Cohort 2
  arm group type: Experimental
  description: Participants will receive dose B of SK10 (n=6) or placebo (n=2)
  arm group label: Cohort 3
  arm group type: Experimental
  description: Participants will receive dose C of SK10 (n=6) or placebo (n=2)
  intervention type: Drug
  intervention name: SK10
  description: Participants will be randomized to receive oral suspension of SK10 powder, includes SAD on Day 1 and 14-days MAD from Day 4 to Day 17.
  arm group label: Cohort 1
  arm group label: Cohort 2
  arm group label: Cohort 3
  intervention type: Drug
  intervention name: Placebo
  description: Participants will be randomized to receive oral suspension of placebo, includes SAD on Day 1 and 14-days MAD from Day 4 to Day 17.
  arm group label: Cohort 1
  arm group label: Cohort 2
  arm group label: Cohort 3
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 55 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: United States
  responsible party type: Sponsor
  mesh term: Diarrhea