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/NCT05991362</url>
    </required_header>
    <id_info>
      <org_study_id>GFH312X1102</org_study_id>
      <nct_id>NCT05991362</nct_id>
    </id_info>
    <brief_title>A Phase I Study of GFH312 in Healthy Chinese Subjects</brief_title>
    <official_title>A Randomized, Double-blind, Placebo-controlled, Single-dose and Multiple-dose Study Evaluating the Pharmacokinetics and Safety of GFH312 in Healthy Chinese Subjects</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Zhejiang Genfleet Therapeutics Co., Ltd.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Genfleet Therapeutics (Shanghai) Inc.</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The aim of this study was to evaluate the pharmacokinetic profile and observe the safety of&#xD;
        GFH312 after single and multiple administrations in healthy Chinese subjects.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study was planned to enroll about 26 healthy subjects, subjects were planned to receive&#xD;
        single administration of 100 mg GFH312, single administration of 200 mg GFH312, or multiple&#xD;
        administrations of 120 mg GFH312, as well as their matching placebo. Subjects were randomized&#xD;
        in 3:1 ratio in the single dose cohorts and in 4:1 ratio in the multiple dose cohort.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">November 29, 2022</start_date>
    <completion_date type="Actual">May 30, 2023</completion_date>
    <primary_completion_date type="Actual">February 13, 2023</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>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Maximum Observed Plasma Concentration (Cmax) of GFH312</measure>
      <time_frame>For single dose groups 30 minutes pre-dose, and at 0.5, 1, 2, 4, 6, 8, 12 hours on day1; day2, day3, day4.</time_frame>
      <description>The maximum observed plasma concentration (Cmax) was estimated based on the plasma concentrations of GFH312.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Time to peak drug concentration (Tmax) of GFH312</measure>
      <time_frame>For single dose groups 30 minutes pre-dose, and at 0.5, 1, 2, 4, 6, 8, 12 hours on day1; day2, day3, day4.</time_frame>
      <description>The time it takes for a drug to reach the maximum concentration (Cmax) after administration of GFH312</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Terminal Elimination Half Life (t1/2) of GFH312</measure>
      <time_frame>For single dose groups 30 minutes pre-dose, and at 0.5, 1, 2, 4, 6, 8, 12 hours on day1; day2, day3, day4; for multiple doses groups 30 minutes pre-dose, and at 0.5, 1, 2, 4, 8, 12 hours on day 1; day2, day7, day 13, day14, day15.</time_frame>
      <description>The terminal elimination half-life (t1/2) was estimated based on the plasma concentrations of GFH312</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of GFH312</measure>
      <time_frame>For single dose groups 30 minutes pre-dose, and at 0.5, 1, 2, 4, 6, 8, 12 hours on day1; day2, day3, day4.</time_frame>
      <description>The area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC0-last) was estimated based on the plasma concentrations of GFH312</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of GFH312</measure>
      <time_frame>For single dose groups 30 minutes pre-dose, and at 0.5, 1, 2, 4, 6, 8, 12 hours on day1; day2, day3, day4.</time_frame>
      <description>The area under the plasma concentration-time curve from time zero to infinity (AUC 0-inf) was estimated based on the plasma concentrations of GFH312</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The apparent systemic (or total body) clearance from plasma (or serum or blood (CL/F) following extravascular administration of GFH312</measure>
      <time_frame>For single dose groups 30 minutes pre-dose, and at 0.5, 1, 2, 4, 6, 8, 12 hours on day1; day2, day3, day4; for multiple doses groups 30 minutes pre-dose, and at 0.5, 1, 2, 4, 8, 12 hours on day 1; day2, day7, day 13, day14, day15.</time_frame>
      <description>The systemic clearance (CL) was estimated based on the plasma concentrations of GFH312</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The apparent volume of distribution during the terminal elimination phase (Vd/F) following extravascular administration of GFH312</measure>
      <time_frame>For single dose groups 30 minutes pre-dose, and at 0.5, 1, 2, 4, 6, 8, 12 hours on day1; day2, day3, day4; for multiple doses groups 30 minutes pre-dose, and at 0.5, 1, 2, 4, 8, 12 hours on day 1; day2, day7, day 13, day14, day15.</time_frame>
      <description>The volume of distribution was estimated based on the plasma concentrations of GFH312</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The observed maximum plasma (or serum or blood) concentration following drug administration at steady state (Cmax,ss)</measure>
      <time_frame>For multiple doses groups 30 minutes pre-dose, and at 0.5, 1, 2, 4, 8, 12 hours on day 1; day2, day7, day 13, day14, day15.</time_frame>
      <description>Observed maximum concentration in the dosing interval at steady state</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The lowest plasma (or serum or blood) concentration observed during a dosing interval at steady state (Cmin,ss)</measure>
      <time_frame>For multiple doses groups 30 minutes pre-dose, and at 0.5, 1, 2, 4, 8, 12 hours on day 1; day2, day7, day 13, day14, day15.</time_frame>
      <description>Observed minimum concentration in the dosing interval at steady state.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Time to reach maximum concentration in the dosing interval at steady state (Tmax,ss)</measure>
      <time_frame>For multiple doses groups 30 minutes pre-dose, and at 0.5, 1, 2, 4, 8, 12 hours on day 1; day2, day7, day 13, day14, day15.</time_frame>
      <description>If the same Cmax concentration occurs at different time points, Tmax is assigned to the first occurrence of Cmax.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The area under the plasma (or serum or blood) concentration-time curve from time zero to the end of the dosing interval tau (AUCtau,ss)</measure>
      <time_frame>For multiple doses groups 30 minutes pre-dose, and at 0.5, 1, 2, 4, 8, 12 hours on day 1; day2, day7, day 13, day14, day15.</time_frame>
      <description>Dose-normalized AUC0- τ, calculated as AUC0-τ divided by actual dose administered.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)</measure>
      <time_frame>up to 30 days after the last study drug administration</time_frame>
      <description>An adverse event (AE) is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening situation (immediate risk of dying); persistent or significant disability or incapacity; congenital anomaly or birth defect in the offspring of a participant who received the study drug.</description>
    </secondary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Actual">26</enrollment>
    <condition>Healthy Volunteer</condition>
    <arm_group>
      <arm_group_label>SAD:100mg</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants received single PO dose of GFH312 100 mg.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>SAD:200mg</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants received single PO dose of GFH312 200 mg.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>MAD:120mg</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants received multiple PO doses of GFH312 120 mg for 14 days.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Participants receiving placebo matching with the GFH312 dose groups</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>GFH312 100 mg</intervention_name>
      <description>Participants receive single dose of GFH312 100 mg orally</description>
      <arm_group_label>SAD:100mg</arm_group_label>
      <other_name>GFH312</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>GFH312 200 mg</intervention_name>
      <description>Participants receive single dose of GFH312 200 mg orally</description>
      <arm_group_label>SAD:200mg</arm_group_label>
      <other_name>GFH312</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>GFH312 120mg</intervention_name>
      <description>Participants receive daily dose of GFH312 120mg orally for fourteen consecutive days</description>
      <arm_group_label>MAD:120mg</arm_group_label>
      <other_name>GFH312</other_name>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Participants receive placebo matching with GFH312</description>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Voluntarily participate in the study and sign the informed consent;&#xD;
  &#xD;
            -  Male or female healthy subjects aged 18-55 years (inclusive) (single sex ratio not&#xD;
               less than 25% of the sample size of each cohort);&#xD;
  &#xD;
            -  Body mass index (BMI) between 18-28 kg/m2 (inclusive), and weight ≥ 50kg; BMI = Weight&#xD;
               (kg) /[Height (m)]2.&#xD;
  &#xD;
            -  During the screening period and day 1, patients with normal or abnormal results but no&#xD;
               clinical significance based on detailed medical history, comprehensive physical&#xD;
               examination, laboratory examination (blood routine, blood biochemistry, urine routine,&#xD;
               coagulation function), 12-lead electrocardiogram and vital signs.&#xD;
  &#xD;
            -  Able to communicate well with researchers, understand and comply with research&#xD;
               requirements.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Any procedure or disease that may significantly alter drug absorption, distribution,&#xD;
               metabolism, or excretion, or participation in this study may compromise the safety of&#xD;
               the subject.&#xD;
  &#xD;
            -  Tuberculin test positive&#xD;
  &#xD;
            -  Abnormal electrocardiogram with clinical significance&#xD;
  &#xD;
            -  Use any prescription drugs, Chinese herbs and/or OTC or health products within 2 weeks&#xD;
               before starting the administration.&#xD;
  &#xD;
            -  Women who are pregnant or breastfeeding, or subjects with positive pregnancy test&#xD;
               results at the time of screening or at baseline, or who plan to become pregnant during&#xD;
               the study period or within 30 days after the end of the study.&#xD;
  &#xD;
            -  Subjects who have any factors deemed unsuitable for participation in this study by the&#xD;
               investigator.&#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>LU Yongning, PHD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Wuhan Union Hospital, China</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Union Hospital, Tongji Medical College, Huazhong University of Science and Technology</name>
        <address>
          <city>Wuhan</city>
          <state>Hubei</state>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 6, 2023</study_first_submitted>
    <study_first_submitted_qc>August 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 20, 2023</last_update_submitted>
    <last_update_submitted_qc>August 20, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <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/NCT05991362
  org study id: GFH312X1102
  nct id: NCT05991362
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The aim of this study was to evaluate the pharmacokinetic profile and observe the safety of
        GFH312 after single and multiple administrations in healthy Chinese subjects.
  This study was planned to enroll about 26 healthy subjects, subjects were planned to receive
        single administration of 100 mg GFH312, single administration of 200 mg GFH312, or multiple
        administrations of 120 mg GFH312, as well as their matching placebo. Subjects were randomized
        in 3:1 ratio in the single dose cohorts and in 4:1 ratio in the multiple dose cohort.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Investigator)
  measure: Maximum Observed Plasma Concentration (Cmax) of GFH312
  time frame: For single dose groups 30 minutes pre-dose, and at 0.5, 1, 2, 4, 6, 8, 12 hours on day1; day2, day3, day4.
  description: The maximum observed plasma concentration (Cmax) was estimated based on the plasma concentrations of GFH312.
  measure: Time to peak drug concentration (Tmax) of GFH312
  time frame: For single dose groups 30 minutes pre-dose, and at 0.5, 1, 2, 4, 6, 8, 12 hours on day1; day2, day3, day4.
  description: The time it takes for a drug to reach the maximum concentration (Cmax) after administration of GFH312
  measure: Terminal Elimination Half Life (t1/2) of GFH312
  time frame: For single dose groups 30 minutes pre-dose, and at 0.5, 1, 2, 4, 6, 8, 12 hours on day1; day2, day3, day4; for multiple doses groups 30 minutes pre-dose, and at 0.5, 1, 2, 4, 8, 12 hours on day 1; day2, day7, day 13, day14, day15.
  description: The terminal elimination half-life (t1/2) was estimated based on the plasma concentrations of GFH312
  measure: Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of GFH312
  time frame: For single dose groups 30 minutes pre-dose, and at 0.5, 1, 2, 4, 6, 8, 12 hours on day1; day2, day3, day4.
  description: The area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC0-last) was estimated based on the plasma concentrations of GFH312
  measure: Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of GFH312
  time frame: For single dose groups 30 minutes pre-dose, and at 0.5, 1, 2, 4, 6, 8, 12 hours on day1; day2, day3, day4.
  description: The area under the plasma concentration-time curve from time zero to infinity (AUC 0-inf) was estimated based on the plasma concentrations of GFH312
  measure: The apparent systemic (or total body) clearance from plasma (or serum or blood (CL/F) following extravascular administration of GFH312
  time frame: For single dose groups 30 minutes pre-dose, and at 0.5, 1, 2, 4, 6, 8, 12 hours on day1; day2, day3, day4; for multiple doses groups 30 minutes pre-dose, and at 0.5, 1, 2, 4, 8, 12 hours on day 1; day2, day7, day 13, day14, day15.
  description: The systemic clearance (CL) was estimated based on the plasma concentrations of GFH312
  measure: The apparent volume of distribution during the terminal elimination phase (Vd/F) following extravascular administration of GFH312
  time frame: For single dose groups 30 minutes pre-dose, and at 0.5, 1, 2, 4, 6, 8, 12 hours on day1; day2, day3, day4; for multiple doses groups 30 minutes pre-dose, and at 0.5, 1, 2, 4, 8, 12 hours on day 1; day2, day7, day 13, day14, day15.
  description: The volume of distribution was estimated based on the plasma concentrations of GFH312
  measure: The observed maximum plasma (or serum or blood) concentration following drug administration at steady state (Cmax,ss)
  time frame: For multiple doses groups 30 minutes pre-dose, and at 0.5, 1, 2, 4, 8, 12 hours on day 1; day2, day7, day 13, day14, day15.
  description: Observed maximum concentration in the dosing interval at steady state
  measure: The lowest plasma (or serum or blood) concentration observed during a dosing interval at steady state (Cmin,ss)
  time frame: For multiple doses groups 30 minutes pre-dose, and at 0.5, 1, 2, 4, 8, 12 hours on day 1; day2, day7, day 13, day14, day15.
  description: Observed minimum concentration in the dosing interval at steady state.
  measure: Time to reach maximum concentration in the dosing interval at steady state (Tmax,ss)
  time frame: For multiple doses groups 30 minutes pre-dose, and at 0.5, 1, 2, 4, 8, 12 hours on day 1; day2, day7, day 13, day14, day15.
  description: If the same Cmax concentration occurs at different time points, Tmax is assigned to the first occurrence of Cmax.
  measure: The area under the plasma (or serum or blood) concentration-time curve from time zero to the end of the dosing interval tau (AUCtau,ss)
  time frame: For multiple doses groups 30 minutes pre-dose, and at 0.5, 1, 2, 4, 8, 12 hours on day 1; day2, day7, day 13, day14, day15.
  description: Dose-normalized AUC0- τ, calculated as AUC0-τ divided by actual dose administered.
  measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
  time frame: up to 30 days after the last study drug administration
  description: An adverse event (AE) is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening situation (immediate risk of dying); persistent or significant disability or incapacity; congenital anomaly or birth defect in the offspring of a participant who received the study drug.
  arm group label: SAD:100mg
  arm group type: Experimental
  description: Participants received single PO dose of GFH312 100 mg.
  arm group label: SAD:200mg
  arm group type: Experimental
  description: Participants received single PO dose of GFH312 200 mg.
  arm group label: MAD:120mg
  arm group type: Experimental
  description: Participants received multiple PO doses of GFH312 120 mg for 14 days.
  arm group label: Placebo
  arm group type: Placebo Comparator
  description: Participants receiving placebo matching with the GFH312 dose groups
  intervention type: Drug
  intervention name: GFH312 100 mg
  description: Participants receive single dose of GFH312 100 mg orally
  arm group label: SAD:100mg
  other name: GFH312
  intervention type: Drug
  intervention name: GFH312 200 mg
  description: Participants receive single dose of GFH312 200 mg orally
  arm group label: SAD:200mg
  other name: GFH312
  intervention type: Drug
  intervention name: GFH312 120mg
  description: Participants receive daily dose of GFH312 120mg orally for fourteen consecutive days
  arm group label: MAD:120mg
  other name: GFH312
  intervention type: Other
  intervention name: Placebo
  description: Participants receive placebo matching with GFH312
  arm group label: Placebo
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 55 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: LU Yongning, PHD
  role: Principal Investigator
  affiliation: Wuhan Union Hospital, China
  facility: 
  country: China
  responsible party type: Sponsor
  sharing ipd: No