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/NCT05977140</url>
    </required_header>
    <id_info>
      <org_study_id>CDI-988-P1-001</org_study_id>
      <nct_id>NCT05977140</nct_id>
    </id_info>
    <brief_title>CDI-988 Safety Study in Healthy Participants</brief_title>
    <official_title>A Phase 1, Randomized, Double-Blinded, Placebo-Controlled, First-in-Human Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single-Ascending and Multiple-Ascending Doses of Oral CDI-988 in Healthy Adult Participants</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Cocrystal Pharma, Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Cocrystal Pharma Australia Pty Ltd.</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Nucleus Network Pty Ltd.</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Beyond Drug Development Pty Ltd.</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Resolutum Global Pty Ltd.</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Cocrystal Pharma, 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>
        The goal of this clinical trial is to learn about the safety and pharmacokinetics (PK, the&#xD;
        amount of drug in the blood) of a new drug called CDI-988 in healthy volunteers.&#xD;
  &#xD;
        The main questions it aims to answer are:&#xD;
  &#xD;
          -  Are there any side effects of the drug?&#xD;
  &#xD;
          -  What is the amount of drug that reaches the bloodstream? Participants will be assigned&#xD;
             by chance to take either CDI-988 or placebo by mouth and have physical exams,&#xD;
             electrocardiograms (ECGs), vital signs, and blood tests to look for any side effects.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        CDI-988 is a severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) 3-chymotrypsin-like&#xD;
        (3CL) protease inhibitor for oral administration. This study is being conducted in 2 parts to&#xD;
        examine the safety, tolerability, and PK of CDI-988 in healthy participants. Part 1 will&#xD;
        entail escalating single doses in sequential cohorts and Part 2 will enroll escalating&#xD;
        multiple-dose cohorts. Participants will be monitored for adverse events, vital signs,&#xD;
        laboratory values, and electrocardiograms (ECGs).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">November 2024</completion_date>
    <primary_completion_date type="Anticipated">November 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>
      <intervention_model_description>4 single-ascending-dose (SAD) cohorts, including food-effect cohort 3 multiple-ascending-dose (MAD) cohorts 8 participants per cohort (6 active and 2 placebo)</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Adverse events</measure>
      <time_frame>Day 1 to 7 days after last dose</time_frame>
      <description>number of participants with treatment-emergent adverse events</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Laboratory abnormalities</measure>
      <time_frame>Day 1 to 7 days after last dose</time_frame>
      <description>number of participants with clinically significant laboratory abnormalities</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Vital signs</measure>
      <time_frame>Day 1 to 7 days after last dose</time_frame>
      <description>number of participants with clinically significant changes from baseline in vital signs</description>
    </primary_outcome>
    <primary_outcome>
      <measure>ECGs</measure>
      <time_frame>Day 1 to 7 days after last dose</time_frame>
      <description>number of participants with clinically significant changes from baseline in ECGs</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Maximum plasma concentration (Cmax)</measure>
      <time_frame>Day 1 to 3 days after last dose</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time of maximum plasma concentration (Tmax)</measure>
      <time_frame>Day 1 to 7 days after last dose</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Area under the plasma concentration-time curve (AUC)</measure>
      <time_frame>Day 1 to 3 days after last dose</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Elimination rate constant (lambda Z)</measure>
      <time_frame>Day 1 to 3 days after last dose</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Terminal elimination half-life (t1/2)</measure>
      <time_frame>Day 1 to 3 days after last dose</time_frame>
    </secondary_outcome>
    <number_of_arms>7</number_of_arms>
    <enrollment type="Anticipated">56</enrollment>
    <condition>Healthy Volunteers</condition>
    <arm_group>
      <arm_group_label>SAD Cohort 1A</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>first single-dose level</description>
    </arm_group>
    <arm_group>
      <arm_group_label>SAD Cohort 1B</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>second single-dose level</description>
    </arm_group>
    <arm_group>
      <arm_group_label>SAD Cohort 1C</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>third single-dose level; food-effect cohort</description>
    </arm_group>
    <arm_group>
      <arm_group_label>SAD Cohort 1D</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>fourth single-dose level</description>
    </arm_group>
    <arm_group>
      <arm_group_label>MAD Cohort 2A</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>first multiple-dose level</description>
    </arm_group>
    <arm_group>
      <arm_group_label>MAD Cohort 2B</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>second multiple-dose level</description>
    </arm_group>
    <arm_group>
      <arm_group_label>MAD Cohort 2C</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>third multiple-dose level</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>CDI-988</intervention_name>
      <description>SARS-CoV-2 3CL protease inhibitor</description>
      <arm_group_label>MAD Cohort 2A</arm_group_label>
      <arm_group_label>MAD Cohort 2B</arm_group_label>
      <arm_group_label>MAD Cohort 2C</arm_group_label>
      <arm_group_label>SAD Cohort 1A</arm_group_label>
      <arm_group_label>SAD Cohort 1B</arm_group_label>
      <arm_group_label>SAD Cohort 1C</arm_group_label>
      <arm_group_label>SAD Cohort 1D</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>matching placebo</description>
      <arm_group_label>MAD Cohort 2A</arm_group_label>
      <arm_group_label>MAD Cohort 2B</arm_group_label>
      <arm_group_label>MAD Cohort 2C</arm_group_label>
      <arm_group_label>SAD Cohort 1A</arm_group_label>
      <arm_group_label>SAD Cohort 1B</arm_group_label>
      <arm_group_label>SAD Cohort 1C</arm_group_label>
      <arm_group_label>SAD Cohort 1D</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Healthy males or non-pregnant, non-lactating females&#xD;
  &#xD;
            -  Body weight of at least 45 kg.&#xD;
  &#xD;
            -  Body mass index ≥18.0 and ≤32.0 kg/m2&#xD;
  &#xD;
            -  Good state of mental and physical health&#xD;
  &#xD;
            -  Negative severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Received an investigational drug within 30 days&#xD;
  &#xD;
            -  Received a coronavirus disease 2019 (COVID-19) vaccine within 7 days&#xD;
  &#xD;
            -  Drug or alcohol abuse in the past 12 months&#xD;
  &#xD;
            -  Clinically significant abnormal biochemistry, hematology, coagulation, urinalysis test&#xD;
               results&#xD;
  &#xD;
            -  Clinically significant abnormal ECG or vital signs&#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>
    <overall_official>
      <last_name>Philip Ryan, MD, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Nucleus Network</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Sam Lee, PhD</last_name>
      <phone>425-750-7208</phone>
      <email>slee@cocrystalpharma.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Carolyn A Luscombe, PhD</last_name>
      <phone>+61(0) 458 271 946</phone>
      <email>cluscombe@cocrystalpharma.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Nucleus Network Pty Ltd</name>
        <address>
          <city>Melbourne</city>
          <state>Victoria</state>
          <zip>3004</zip>
          <country>Australia</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Australia</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 28, 2023</study_first_submitted>
    <study_first_submitted_qc>July 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>July 28, 2023</last_update_submitted>
    <last_update_submitted_qc>July 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 4, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Coronavirus</keyword>
    <keyword>SARS-CoV-2</keyword>
    <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/NCT05977140
  org study id: CDI-988-P1-001
  nct id: NCT05977140
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to learn about the safety and pharmacokinetics (PK, the
        amount of drug in the blood) of a new drug called CDI-988 in healthy volunteers.
  
        The main questions it aims to answer are:
  
          -  Are there any side effects of the drug?
  
          -  What is the amount of drug that reaches the bloodstream? Participants will be assigned
             by chance to take either CDI-988 or placebo by mouth and have physical exams,
             electrocardiograms (ECGs), vital signs, and blood tests to look for any side effects.
  CDI-988 is a severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) 3-chymotrypsin-like
        (3CL) protease inhibitor for oral administration. This study is being conducted in 2 parts to
        examine the safety, tolerability, and PK of CDI-988 in healthy participants. Part 1 will
        entail escalating single doses in sequential cohorts and Part 2 will enroll escalating
        multiple-dose cohorts. Participants will be monitored for adverse events, vital signs,
        laboratory values, and electrocardiograms (ECGs).
  allocation: Randomized
  intervention model: Sequential Assignment
  intervention model description: 4 single-ascending-dose (SAD) cohorts, including food-effect cohort 3 multiple-ascending-dose (MAD) cohorts 8 participants per cohort (6 active and 2 placebo)
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Adverse events
  time frame: Day 1 to 7 days after last dose
  description: number of participants with treatment-emergent adverse events
  measure: Laboratory abnormalities
  time frame: Day 1 to 7 days after last dose
  description: number of participants with clinically significant laboratory abnormalities
  measure: Vital signs
  time frame: Day 1 to 7 days after last dose
  description: number of participants with clinically significant changes from baseline in vital signs
  measure: ECGs
  time frame: Day 1 to 7 days after last dose
  description: number of participants with clinically significant changes from baseline in ECGs
  measure: Maximum plasma concentration (Cmax)
  time frame: Day 1 to 3 days after last dose
  measure: Time of maximum plasma concentration (Tmax)
  time frame: Day 1 to 7 days after last dose
  measure: Area under the plasma concentration-time curve (AUC)
  time frame: Day 1 to 3 days after last dose
  measure: Elimination rate constant (lambda Z)
  time frame: Day 1 to 3 days after last dose
  measure: Terminal elimination half-life (t1/2)
  time frame: Day 1 to 3 days after last dose
  arm group label: SAD Cohort 1A
  arm group type: Experimental
  description: first single-dose level
  arm group label: SAD Cohort 1B
  arm group type: Experimental
  description: second single-dose level
  arm group label: SAD Cohort 1C
  arm group type: Experimental
  description: third single-dose level; food-effect cohort
  arm group label: SAD Cohort 1D
  arm group type: Experimental
  description: fourth single-dose level
  arm group label: MAD Cohort 2A
  arm group type: Experimental
  description: first multiple-dose level
  arm group label: MAD Cohort 2B
  arm group type: Experimental
  description: second multiple-dose level
  arm group label: MAD Cohort 2C
  arm group type: Experimental
  description: third multiple-dose level
  intervention type: Drug
  intervention name: CDI-988
  description: SARS-CoV-2 3CL protease inhibitor
  arm group label: MAD Cohort 2A
  arm group label: MAD Cohort 2B
  arm group label: MAD Cohort 2C
  arm group label: SAD Cohort 1A
  arm group label: SAD Cohort 1B
  arm group label: SAD Cohort 1C
  arm group label: SAD Cohort 1D
  intervention type: Drug
  intervention name: Placebo
  description: matching placebo
  arm group label: MAD Cohort 2A
  arm group label: MAD Cohort 2B
  arm group label: MAD Cohort 2C
  arm group label: SAD Cohort 1A
  arm group label: SAD Cohort 1B
  arm group label: SAD Cohort 1C
  arm group label: SAD Cohort 1D
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 55 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Philip Ryan, MD, PhD
  role: Principal Investigator
  affiliation: Nucleus Network
  last name: Sam Lee, PhD
  phone: 425-750-7208
  email: slee@cocrystalpharma.com
  last name: Carolyn A Luscombe, PhD
  phone: +61(0) 458 271 946
  email: cluscombe@cocrystalpharma.com
  facility: 
  country: Australia
  responsible party type: Sponsor
  sharing ipd: No