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/NCT05984368</url>
    </required_header>
    <id_info>
      <org_study_id>BG136211213</org_study_id>
      <nct_id>NCT05984368</nct_id>
    </id_info>
    <brief_title>A Clinical Study of BG136 Injection in Healthy Chinese Volunteers</brief_title>
    <official_title>First-in-Human, Randomized, Double-Blind, Placebo-Controlled, Single Dose Escalation and Multiple Dose Escalation Phase I Clinical Trial of BG136 for Injection in Healthy Subjects</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>The Affiliated Hospital of Qingdao University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>The Affiliated Hospital of Qingdao University</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>
        This is a first-in-human, randomized, double-blind, placebo-controlled trial in healthy&#xD;
        subjects. The trial consisted of two parts: part 1: single ascending dose (SAD) study and&#xD;
        part 2: multiple ascending dose (MAD) study. Each part had multiple Intravenous infusion&#xD;
        administration dose groups. Prior to the formal initiation of the dose-escalation trial, the&#xD;
        safety, tolerability, and pharmacokinetics (PK) characteristics of a pretest dose (pilot&#xD;
        dose) of 2 mg will be evaluated in 2 subjects (both administered BG136 for injection)&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a first-in-human, randomized, double-blind, placebo-controlled clinical trial in&#xD;
        healthy subjects. The trial consists of two parts: Part 1: a single ascending dose (SAD)&#xD;
        study with seven dose groups: 2 mg (exploratory dose), 24 mg, 50 mg, 100 mg, 200 mg, and 300&#xD;
        mg, 400 mg (optional dose groups), with two subjects enrolled in the 2 mg group (all&#xD;
        receiving the test drug), and eight subjects enrolled in each of the remaining groups (six&#xD;
        test drug and two placebo); Part 2: a multiple ascending dose (MAD) study with seven dose&#xD;
        groups: two subjects (six test drug and two placebo); and Part III: a randomized,&#xD;
        double-blind, placebo-controlled clinical trial in healthy subjects, with a randomized,&#xD;
        double-blind, placebo-controlled clinical trial in healthy subjects. Part II: Multiple&#xD;
        ascending dose (MAD) study, divided into 3 dose groups: 100 mg, 200 mg and 300 mg, each&#xD;
        including 8 healthy subjects (6 test drug, 2 placebo).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 18, 2023</start_date>
    <completion_date type="Anticipated">May 6, 2024</completion_date>
    <primary_completion_date type="Anticipated">September 5, 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>Sequential Assignment</intervention_model>
      <intervention_model_description>Single-dose and multi-dose, dose escalation, placebo-controlled study</intervention_model_description>
      <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-related adverse events as assessed by CTCAE v5.0</measure>
      <time_frame>up to 14 days</time_frame>
      <description>Number of participants with treatment-related adverse events as assessed by CTCAE v5.0</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Peak Plasma Concentration (Cmax)</measure>
      <time_frame>up to 14 days</time_frame>
      <description>Evaluation of Peak Plasma Concentration (Cmax)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Area under the plasma concentration versus time curve (AUC)0-t</measure>
      <time_frame>up to 14 days</time_frame>
      <description>Evaluation of Area under the plasma concentration versus time curve (AUC)0-t</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Area under the plasma concentration versus time curve (AUC)0-∞</measure>
      <time_frame>up to 14 days</time_frame>
      <description>Evaluation of Area under the plasma concentration versus time curve (AUC)0-∞</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">74</enrollment>
    <condition>Healthy</condition>
    <arm_group>
      <arm_group_label>Part 1</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>A single ascending dose (SAD) study divided into 7 dose groups: 2 mg (exploratory dose), 24 mg, 50 mg, 100 mg, 200 mg, and 300 mg, 400 mg (optional dose group), with 2 mg enrolling 2 subjects (all receiving the test drug) and the remaining 8 subjects in each group (6 test drug, 2 placebo).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Part 2</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Multiple ascending dose (MAD) study, divided into 3 dose groups: 100 mg, 200 mg and 300 mg, each group included 8 healthy subjects (6 test drug, 2 placebo).</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>BG136</intervention_name>
      <description>Subjects injected with BG136 in Part 1 and Part 2</description>
      <arm_group_label>Part 1</arm_group_label>
      <arm_group_label>Part 2</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Subjects injected with Placebo in Part 1 and Part 2</description>
      <arm_group_label>Part 1</arm_group_label>
      <arm_group_label>Part 2</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Chinese male or female subjects aged 18-55 years (including the threshold);&#xD;
  &#xD;
            -  Weight ≥ 50 kg for men and ≥ 45 kg for women and body mass index (BMI): 19.0-26.0&#xD;
               kg/m2 (including borderline values);&#xD;
  &#xD;
            -  Subjects understand and comply with the study process, can communicate well with the&#xD;
               investigator, volunteer to participate in the trial and sign an informed consent form.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Diseases to be excluded due to clinical abnormalities within 3 months prior to&#xD;
               screening, including but not limited to neurological/psychiatric, cardiovascular,&#xD;
               hematological and lymphatic, immune, gastrointestinal, urinary, endocrine, metabolic,&#xD;
               and skeletal conditions. History of diseases of the urinary, endocrine, respiratory,&#xD;
               metabolic and skeletal systems.&#xD;
  &#xD;
            -  History of comorbid gastrointestinal related disorders&#xD;
  &#xD;
            -  Those who have had surgery within 3 months prior to screening or plan to have surgery&#xD;
               during the study period；&#xD;
  &#xD;
            -  Screening subjects whose vital signs, physical examination, routine blood, urine,&#xD;
               blood biochemistry, coagulation function, and electrocardiogram are judged by the&#xD;
               investigator to be abnormal and clinically significant；&#xD;
  &#xD;
            -  Subject's imaging determined by the investigator to be clinically significant for&#xD;
               abnormalities；&#xD;
  &#xD;
            -  Hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody screening, human&#xD;
               immunodeficiency virus (HIV) antibody screening, treponema pallidum antibody (TP-Ab)&#xD;
               any test positive；&#xD;
  &#xD;
            -  History of food or drug allergies or other allergic diseases；&#xD;
  &#xD;
            -  History of substance abuse in the 12 months prior to screening, or drug use in the 3&#xD;
               months prior to screening, or a positive urine drug screen；&#xD;
  &#xD;
            -  Positive breath test results for alcohol or regular alcohol consumption in the 6&#xD;
               months prior to screening, i.e., an average of more than 14 units of alcohol per week&#xD;
               (1 unit ≈ 200 mL of beer at 5% alcohol or 25 mL of spirits at 40% alcohol or 85 mL of&#xD;
               wine at 12% alcohol), or inability to abstain from alcohol consumption for 48 hours&#xD;
               prior to the first dose of the medication and for the entire study period；&#xD;
  &#xD;
            -  Smokers who smoked an average of ≥5 cigarettes per day in the 3 months prior to&#xD;
               screening or who could not give up smoking 48 hours prior to the first dose and&#xD;
               throughout the study period；&#xD;
  &#xD;
            -  Those who have received a blood transfusion or used blood products ≥ 400 mL or 2 units&#xD;
               within 3 months prior to screening, or those who have lost ≥ 400 mL of blood within 6&#xD;
               months, or those who have donated blood within 3 months；&#xD;
  &#xD;
            -  Participated in another clinical trial within 3 months prior to screening and took the&#xD;
               trial drug or used the trial device；&#xD;
  &#xD;
            -  Any prescription (including vaccines), over-the-counter medications used within 4&#xD;
               weeks prior to screening；&#xD;
  &#xD;
            -  Those who have used herbal medicines or health supplements for the treatment and/or&#xD;
               prevention of their own disease within 2 weeks prior to screening；&#xD;
  &#xD;
            -  Persons with special dietary requirements who are unable to follow a standardized diet&#xD;
               or who are unable to avoid xanthine-rich beverages or foods or fruits or fruit juices&#xD;
               that may interfere with metabolism for 48 hours prior to dosing and up to study&#xD;
               completion;&#xD;
  &#xD;
            -  Those who have difficulty in collecting blood from veins or who suffer from needle;&#xD;
  &#xD;
            -  Women who are pregnant, breastfeeding, or who have had unprotected sex within 2 weeks&#xD;
               prior to screening, or who have had a positive pre-test pregnancy test;&#xD;
  &#xD;
            -  Male subjects (or their partners) or female subjects who are planning a pregnancy,&#xD;
               sperm donation, or oocyte donation from the time of signing the Informed Consent Form&#xD;
               until 3 months after the end of the administration of the medication;&#xD;
  &#xD;
            -  Those who do not wish to use one of the medically approved non-pharmacological&#xD;
               contraceptives (e.g., intrauterine device or condom) during the trial period;&#xD;
  &#xD;
            -  Subjects deemed unsuitable by the investigator to participate in 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>
    <overall_official>
      <last_name>Yu Cao, doctor</last_name>
      <role>Principal Investigator</role>
      <affiliation>The Affiliated Hospital of Qingdao University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Yu Cao, doctor</last_name>
      <phone>86-18661809090</phone>
      <email>caoyu1767@126.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Affiliated Hospital of Qingdao University Phase I Clinical Research Center</name>
        <address>
          <city>Qingdao</city>
          <state>Shandong</state>
          <zip>266003</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Yu Cao, Dr</last_name>
        <phone>86-18661809090</phone>
        <email>caoyu1767@126.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 25, 2023</study_first_submitted>
    <study_first_submitted_qc>August 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 9, 2023</study_first_posted>
    <last_update_submitted>August 27, 2023</last_update_submitted>
    <last_update_submitted_qc>August 27, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>The Affiliated Hospital of Qingdao University</investigator_affiliation>
      <investigator_full_name>Cao Yu</investigator_full_name>
      <investigator_title>Director of Clinical Trials Center of Affiliated Hospital of Qingdao University</investigator_title>
    </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/NCT05984368
  org study id: BG136211213
  nct id: NCT05984368
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This is a first-in-human, randomized, double-blind, placebo-controlled trial in healthy
        subjects. The trial consisted of two parts: part 1: single ascending dose (SAD) study and
        part 2: multiple ascending dose (MAD) study. Each part had multiple Intravenous infusion
        administration dose groups. Prior to the formal initiation of the dose-escalation trial, the
        safety, tolerability, and pharmacokinetics (PK) characteristics of a pretest dose (pilot
        dose) of 2 mg will be evaluated in 2 subjects (both administered BG136 for injection)
  This is a first-in-human, randomized, double-blind, placebo-controlled clinical trial in
        healthy subjects. The trial consists of two parts: Part 1: a single ascending dose (SAD)
        study with seven dose groups: 2 mg (exploratory dose), 24 mg, 50 mg, 100 mg, 200 mg, and 300
        mg, 400 mg (optional dose groups), with two subjects enrolled in the 2 mg group (all
        receiving the test drug), and eight subjects enrolled in each of the remaining groups (six
        test drug and two placebo); Part 2: a multiple ascending dose (MAD) study with seven dose
        groups: two subjects (six test drug and two placebo); and Part III: a randomized,
        double-blind, placebo-controlled clinical trial in healthy subjects, with a randomized,
        double-blind, placebo-controlled clinical trial in healthy subjects. Part II: Multiple
        ascending dose (MAD) study, divided into 3 dose groups: 100 mg, 200 mg and 300 mg, each
        including 8 healthy subjects (6 test drug, 2 placebo).
  allocation: Randomized
  intervention model: Sequential Assignment
  intervention model description: Single-dose and multi-dose, dose escalation, placebo-controlled study
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
  time frame: up to 14 days
  description: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
  measure: Peak Plasma Concentration (Cmax)
  time frame: up to 14 days
  description: Evaluation of Peak Plasma Concentration (Cmax)
  measure: Area under the plasma concentration versus time curve (AUC)0-t
  time frame: up to 14 days
  description: Evaluation of Area under the plasma concentration versus time curve (AUC)0-t
  measure: Area under the plasma concentration versus time curve (AUC)0-∞
  time frame: up to 14 days
  description: Evaluation of Area under the plasma concentration versus time curve (AUC)0-∞
  arm group label: Part 1
  arm group type: Experimental
  description: A single ascending dose (SAD) study divided into 7 dose groups: 2 mg (exploratory dose), 24 mg, 50 mg, 100 mg, 200 mg, and 300 mg, 400 mg (optional dose group), with 2 mg enrolling 2 subjects (all receiving the test drug) and the remaining 8 subjects in each group (6 test drug, 2 placebo).
  arm group label: Part 2
  arm group type: Experimental
  description: Multiple ascending dose (MAD) study, divided into 3 dose groups: 100 mg, 200 mg and 300 mg, each group included 8 healthy subjects (6 test drug, 2 placebo).
  intervention type: Drug
  intervention name: BG136
  description: Subjects injected with BG136 in Part 1 and Part 2
  arm group label: Part 1
  arm group label: Part 2
  intervention type: Drug
  intervention name: Placebo
  description: Subjects injected with Placebo in Part 1 and Part 2
  arm group label: Part 1
  arm group label: Part 2
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 55 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Yu Cao, doctor
  role: Principal Investigator
  affiliation: The Affiliated Hospital of Qingdao University
  last name: Yu Cao, doctor
  phone: 86-18661809090
  email: caoyu1767@126.com
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: The Affiliated Hospital of Qingdao University
  investigator full name: Cao Yu
  investigator title: Director of Clinical Trials Center of Affiliated Hospital of Qingdao University
  sharing ipd: No