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/NCT06004921</url>
    </required_header>
    <id_info>
      <org_study_id>ARC-26</org_study_id>
      <nct_id>NCT06004921</nct_id>
    </id_info>
    <brief_title>A Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of AB801 in Healthy Volunteers</brief_title>
    <acronym>ARC-26</acronym>
    <official_title>A Phase 1, Double-Blinded, Randomised, Placebo-Controlled, Single Ascending Dose (SAD) Study in Healthy Subjects to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of AB801</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Arcus Biosciences, Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Arcus Biosciences, Inc.</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>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The primary purpose of this study is to determine the safety and tolerability of AB801, and&#xD;
        to understand the pharmacokinetic (PK) profile of AB801 when taken as a capsule and tablet in&#xD;
        healthy volunteers.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">January 2024</completion_date>
    <primary_completion_date type="Anticipated">January 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>Double (Participant, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Number of Participants with Adverse Events (AEs)</measure>
      <time_frame>Up to 30 days</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Area Under the Plasma Drug Concentration-Time Curve (AUC)</measure>
      <time_frame>Predose, Up to 120 hours postdose</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Maximum Concentration (Cmax) in Plasma</measure>
      <time_frame>Predose, Up to 120 hours postdose</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Time to Maximum Concentration (Tmax) in Plasma</measure>
      <time_frame>Predose, Up to 120 hours postdose</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Half-Life Time (t1/2)</measure>
      <time_frame>Predose, Up to 120 hours postdose</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change from Baseline in Holter Electrocardiogram Monitoring Scale</measure>
      <time_frame>Predose up to 25 hours postdose</time_frame>
    </secondary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">32</enrollment>
    <condition>Cancer</condition>
    <arm_group>
      <arm_group_label>Cohort 1 - AB801 Dose A</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive a single dose of AB801 or placebo</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Cohort 2 - AB801 Dose B</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive a single dose of AB801 or placebo</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Cohort 3 - AB801 Dose C</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive a single dose of AB801 or placebo</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Cohort 4 - AB801 Dose D</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive a single dose of AB801 or placebo</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>AB801</intervention_name>
      <description>Administered as specified in the treatment arm</description>
      <arm_group_label>Cohort 1 - AB801 Dose A</arm_group_label>
      <arm_group_label>Cohort 2 - AB801 Dose B</arm_group_label>
      <arm_group_label>Cohort 3 - AB801 Dose C</arm_group_label>
      <arm_group_label>Cohort 4 - AB801 Dose D</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Administered as specified in the treatment arm</description>
      <arm_group_label>Cohort 1 - AB801 Dose A</arm_group_label>
      <arm_group_label>Cohort 2 - AB801 Dose B</arm_group_label>
      <arm_group_label>Cohort 3 - AB801 Dose C</arm_group_label>
      <arm_group_label>Cohort 4 - AB801 Dose D</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Key Inclusion Criteria:&#xD;
  &#xD;
            -  Healthy as determined by medical evaluation by study physician&#xD;
  &#xD;
            -  Body mass index (BMI) of 18.0 to 32.0 kilogram (kg)/meter (m)^2 as measured at&#xD;
               screening&#xD;
  &#xD;
            -  Weight ≥ 50 kg at screening&#xD;
  &#xD;
            -  Must agree to adhere to the protocol defined contraception requirements&#xD;
  &#xD;
          Key Exclusion Criteria:&#xD;
  &#xD;
            -  Do not have suitable veins for multiple venepunctures/cannulation as assessed by the&#xD;
               study physician&#xD;
  &#xD;
            -  Prolonged QT interval defined as mean Corrected QT interval by Fridericia's formula&#xD;
               (QTcF) ≥ 450 msec for males and &gt; 470 millisecond (msec) for females at screening and&#xD;
               pre-dose&#xD;
  &#xD;
            -  Clinically significant abnormal clinical chemistry, haematology or urinalysis as&#xD;
               judged by the study physician&#xD;
  &#xD;
            -  Received any study medicine in a clinical research study within the last 90 days&#xD;
  &#xD;
            -  Taking, or have taken, any prescribed or over-the-counter drugs including gastric acid&#xD;
               reducing agents and including CYP3A inhibitor and/or inducers&#xD;
  &#xD;
          Note: Other protocol defined Inclusion/Exclusion criteria may apply.&#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>Medical Director</last_name>
      <role>Study Director</role>
      <affiliation>Arcus Biosciences</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Medical Director</last_name>
      <phone>+1-510-462-3330</phone>
      <email>ClinicalTrials@arcusbio.com</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 15, 2023</study_first_submitted>
    <study_first_submitted_qc>August 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 31, 2023</last_update_submitted>
    <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>AB801</keyword>
    <keyword>Healthy volunteer</keyword>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Arcus will provide access to individual de-identified participant data and related study documents (e.g., protocol, Statistical Analysis Plan [SAP], Clinical Study Report [CSR]) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions.&#xD;
  For more information, please visit our website.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_url>https://trials.arcusbio.com/our-transparency-policy</ipd_url>
    </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/NCT06004921
  org study id: ARC-26
  nct id: NCT06004921
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: No
  The primary purpose of this study is to determine the safety and tolerability of AB801, and
        to understand the pharmacokinetic (PK) profile of AB801 when taken as a capsule and tablet in
        healthy volunteers.
  allocation: Randomized
  intervention model: Sequential Assignment
  primary purpose: Treatment
  masking: Double (Participant, Investigator)
  measure: Number of Participants with Adverse Events (AEs)
  time frame: Up to 30 days
  measure: Area Under the Plasma Drug Concentration-Time Curve (AUC)
  time frame: Predose, Up to 120 hours postdose
  measure: Maximum Concentration (Cmax) in Plasma
  time frame: Predose, Up to 120 hours postdose
  measure: Time to Maximum Concentration (Tmax) in Plasma
  time frame: Predose, Up to 120 hours postdose
  measure: Half-Life Time (t1/2)
  time frame: Predose, Up to 120 hours postdose
  measure: Change from Baseline in Holter Electrocardiogram Monitoring Scale
  time frame: Predose up to 25 hours postdose
  arm group label: Cohort 1 - AB801 Dose A
  arm group type: Experimental
  description: Participants will receive a single dose of AB801 or placebo
  arm group label: Cohort 2 - AB801 Dose B
  arm group type: Experimental
  description: Participants will receive a single dose of AB801 or placebo
  arm group label: Cohort 3 - AB801 Dose C
  arm group type: Experimental
  description: Participants will receive a single dose of AB801 or placebo
  arm group label: Cohort 4 - AB801 Dose D
  arm group type: Experimental
  description: Participants will receive a single dose of AB801 or placebo
  intervention type: Drug
  intervention name: AB801
  description: Administered as specified in the treatment arm
  arm group label: Cohort 1 - AB801 Dose A
  arm group label: Cohort 2 - AB801 Dose B
  arm group label: Cohort 3 - AB801 Dose C
  arm group label: Cohort 4 - AB801 Dose D
  intervention type: Drug
  intervention name: Placebo
  description: Administered as specified in the treatment arm
  arm group label: Cohort 1 - AB801 Dose A
  arm group label: Cohort 2 - AB801 Dose B
  arm group label: Cohort 3 - AB801 Dose C
  arm group label: Cohort 4 - AB801 Dose D
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 55 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Medical Director
  role: Study Director
  affiliation: Arcus Biosciences
  last name: Medical Director
  phone: +1-510-462-3330
  email: ClinicalTrials@arcusbio.com
  responsible party type: Sponsor
  sharing ipd: Yes
  ipd description: Arcus will provide access to individual de-identified participant data and related study documents (e.g., protocol, Statistical Analysis Plan [SAP], Clinical Study Report [CSR]) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions.
  For more information, please visit our website.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Clinical Study Report (CSR)
  ipd url: https://trials.arcusbio.com/our-transparency-policy