<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/NCT04480294</url>
  </required_header>
  <id_info>
    <org_study_id>HRS5091-101</org_study_id>
    <nct_id>NCT04480294</nct_id>
  </id_info>
  <brief_title>A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Effect of Oral HRS5091 in Healthy Subjects and Chronic Hepatitis B Patients</brief_title>
  <official_title>A Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetics, Pharmacodynamics of Oral HRS5091 in Healthy Subjects With Single or Multiple Dose and Chronic Hepatitis B Patients With Multiple Dose, and Food Effects of HRS5091 in Healthy Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jiangsu HengRui Medicine Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Jiangsu HengRui Medicine Co., Ltd.</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 study is a randomized, Double-Blind, Placebo-Controlled study to evaluate the safety,&#xD;
      tolerability and pharmacokinetics, pharmacodynamics and food effect of HRS5091. The study&#xD;
      will be conducted in three parts sequentially:&#xD;
&#xD;
      Part 1a will consist of 58 healthy subjects, 5 groups. The purpose of this part is to explore&#xD;
      the safety, tolerability and pharmacokinetics of single doses of HRS5091 tablet in healthy&#xD;
      subjects.&#xD;
&#xD;
      Part 1b will consist of 18 healthy subjects and it is one of groups in Part 1a.The purpose of&#xD;
      this part is to explore food effect of HRS5091 in healthy subjects.&#xD;
&#xD;
      Part 1c will consist of 10 healthy subjects, 1 groups. The purpose of this part is to explore&#xD;
      the safety, tolerability and pharmacokinetics of multiple doses of HRS5091 tablet in healthy&#xD;
      subjects.&#xD;
&#xD;
      Part 2 will consist of 30 CHB patients.The purpose of this part is to explore the safety,&#xD;
      tolerability and pharmacokinetics, pharmacodynamics of multiple doses of HRS5091 tablet in&#xD;
      naïve and treatment-discontinued chronic hepatitis B (CHB) patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">July 28, 2020</start_date>
  <completion_date type="Anticipated">November 23, 2021</completion_date>
  <primary_completion_date type="Anticipated">November 23, 2021</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>Other</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The incidence and severity of treatment-related</measure>
    <time_frame>29 DAYS for Group 1.2.4.5; 58 DAYS for Group 3; 42 DAYS for Group 6；56 DAYS for Group 7-9；</time_frame>
    <description>adverse events as assessed by CTCAE v5.0</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum Plasma Concentration [Cmax]</measure>
    <time_frame>0-672 hours after each dose for Group 1-9</time_frame>
    <description>Pharmacokinetic parameters of HRS5091, main metabolite and identified major metabolites in plasma</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the concentration time curve [AUC]</measure>
    <time_frame>0-672 hours after each dose for Group 1-9</time_frame>
    <description>Pharmacokinetic parameters of HRS5091, main metabolite and identified major metabolites in plasma</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to maximum plasma concentration [Tmax]</measure>
    <time_frame>0-672 hours after each dose for Group 1-9</time_frame>
    <description>Pharmacokinetic parameters of HRS5091, main metabolite and identified major metabolites in plasma</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Apparent clearance [CL/F]</measure>
    <time_frame>0-672 hours after each dose for Group 1-9</time_frame>
    <description>Pharmacokinetic parameters of HRS5091, main metabolite and identified major metabolites in plasma</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Half-time [t1/2]</measure>
    <time_frame>0-672 hours after each dose for Group 1-9</time_frame>
    <description>Pharmacokinetic parameters of HRS5091, main metabolite and identified major metabolites in plasma</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Apparent volume of distribution [Vz/F(Vd)]</measure>
    <time_frame>0-672 hours after each dose for Group 1-9</time_frame>
    <description>Pharmacokinetic parameters of HRS5091, main metabolite and identified major metabolites in plasma</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean retention time [MRT]</measure>
    <time_frame>0-672 hours after each dose for Group 1-9</time_frame>
    <description>Pharmacokinetic parameters of HRS5091, main metabolite and identified major metabolites in plasma</description>
  </primary_outcome>
  <number_of_arms>10</number_of_arms>
  <enrollment type="Actual">108</enrollment>
  <condition>Chronic Hepatitis B</condition>
  <arm_group>
    <arm_group_label>Part 1a Treatment group 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention: Drug1: HRS5091, dose 1; Drug2: Placebo Healthy subjects</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 1a Treatment group 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention: Drug1: HRS5091, dose 2; Drug2: Placebo Healthy subjects</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 1a Treatment group 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention: Drug1: HRS5091, dose 3; Drug2: Placebo Healthy subjects</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 1a Treatment group 4</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention: Drug1: HRS5091, dose 4; Drug2: Placebo Healthy subjects</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 1a Treatment group 5</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention: Drug1: HRS5091, dose 5; Drug2: Placebo Healthy subjects</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 1b Treatment group 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention: Drug1: HRS5091, dose 3; Drug2: Placebo Healthy subjects Food effect</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 1c Treatment group 6</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention: Drug1: HRS5091, dose 3; Drug2: Placebo Healthy subjects</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 2 Treatment group 7</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention: Drug1: HRS5091, dose 3; Drug2: Placebo CHB subjects</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 2 Treatment group 8</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention: Drug1: HRS5091, dose 4; Drug2: Placebo CHB subjects</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 2 Treatment group 9</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention: Drug1: HRS5091, dose 5; Drug2: Placebo CHB subjects</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>HRS5091</intervention_name>
    <description>Single dose in group 1-5&#xD;
Multiple doses in group 6-9</description>
    <arm_group_label>Part 1a Treatment group 1</arm_group_label>
    <arm_group_label>Part 1a Treatment group 2</arm_group_label>
    <arm_group_label>Part 1a Treatment group 3</arm_group_label>
    <arm_group_label>Part 1a Treatment group 4</arm_group_label>
    <arm_group_label>Part 1a Treatment group 5</arm_group_label>
    <arm_group_label>Part 1b Treatment group 3</arm_group_label>
    <arm_group_label>Part 1c Treatment group 6</arm_group_label>
    <arm_group_label>Part 2 Treatment group 7</arm_group_label>
    <arm_group_label>Part 2 Treatment group 8</arm_group_label>
    <arm_group_label>Part 2 Treatment group 9</arm_group_label>
    <other_name>Placebo</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy subjects&#xD;
&#xD;
               1. Signed informed consent.&#xD;
&#xD;
               2. Aged 18~55.&#xD;
&#xD;
               3. Body weight ≥ 50 kg for male; ≥ 45 kg for female, body mass index (BMI) between&#xD;
                  18 to 28 kg/m².&#xD;
&#xD;
               4. Vital signs, physical examination, laboratory results are within normal range or&#xD;
                  considered not clinically significant.&#xD;
&#xD;
               5. Female subjects (including partner) of childbearing potential must be using a&#xD;
                  medically acceptable form of birth control.&#xD;
&#xD;
          -  CHB subjects&#xD;
&#xD;
               1. Signed informed consent.&#xD;
&#xD;
               2. Aged 18~65.&#xD;
&#xD;
               3. CHB subjects should meet one of the following two criteria:&#xD;
&#xD;
                    -  IgM(immunoglobulin M) HBcAb negative and HBsAg positive.&#xD;
&#xD;
                    -  Two recorded HBsAg positive, and the time interval between the two tests was&#xD;
                       at least 6 months, one of which was the result of this screening&#xD;
&#xD;
               4. CHB subjects should also meet the following criteria:&#xD;
&#xD;
                    -  No treatment with nucleosides analogues or discontinued treatment with&#xD;
                       nucleosides analogues least 6 months at screening&#xD;
&#xD;
                    -  Have not received interferon therapy or discontinued treatment with&#xD;
                       interferon analogues least 3 months at screening&#xD;
&#xD;
                    -  HBeAg positive，HBV(hepatitis B virus) DNA≥ 20000 IU/mL; HBeAg negative, HBV&#xD;
                       DNA≥ 2000 IU/mL&#xD;
&#xD;
                    -  ALT(Alanine aminotransferase)&gt; 1 ULN(upper limit of normal) by two&#xD;
                       measurements within 6 months before enrollment.The interval between two&#xD;
                       measurements shall exceed 14 days;&#xD;
&#xD;
               5. Female subjects (including partner) of childbearing potential must be using a&#xD;
                  medically acceptable form of birth control.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Healthy subjects&#xD;
&#xD;
               1. Currently suffering from cardiovascular, liver, kidney, digestive, nervous,&#xD;
                  blood, thyroid or mental diseases.&#xD;
&#xD;
               2. Have a digestive system disease or a medical history of severe digestive system&#xD;
                  disease at present or in the past month.&#xD;
&#xD;
               3. Have severe infection, severe trauma or major surgical operations within 3&#xD;
                  months. Plan to receive surgery during the trial and within two weeks after the&#xD;
                  end of the trial.&#xD;
&#xD;
               4. 12-ECG test have clinical significant abnormality or the QT interval (QTc) &gt; 470&#xD;
                  ms(male)/QTc)&gt; 480 ms(male) or&lt;300ms(female).&#xD;
&#xD;
               5. Have a medical history of immune-mediated diseases.&#xD;
&#xD;
               6. Screening for infectious diseases is positive,Including HBsAg, Anti-HCV(hepatitis&#xD;
                  C virus), TPPA(Treponema pallidum particle agglutination assay),&#xD;
                  Anti-HIV.Treponema pallidum antibody screen positive, at the investigator's&#xD;
                  discretion in conjunction with RPR(rapid plasma reagin assay) results.&#xD;
&#xD;
               7. Suspected allergy to any ingredient in the study drug.&#xD;
&#xD;
               8. Have any drug that inhibits or induces liver metabolism within 1 month.&#xD;
&#xD;
               9. Take any prescription drugs, over-the-counter drugs and Chinese herbal medicines&#xD;
                  within 14 days before taking the study drug, or plan to take other drugs during&#xD;
                  the test period.&#xD;
&#xD;
              10. Participated in clinical trials of any drug or medical device within 3 months&#xD;
                  before screening.&#xD;
&#xD;
              11. Had donated blood/blood transfusion≥ 200 mL within 1 months prior to screening or&#xD;
                  donated blood or blood transfusion≥ 450 mL within 3 months prior to screening.&#xD;
&#xD;
              12. The average daily smoking ≥ 5 cigarettes within three months; the average daily&#xD;
                  alcohol intake in a month exceeds 15 g (15 g alcohol is equivalent to 450 mL beer&#xD;
                  or 150 mL wine or 50 mL low-alcohol);&#xD;
&#xD;
              13. Keep smoking, drinking alcohol or consuming caffeinated foods or beverages (more&#xD;
                  than 8 cups, 1 cup = 250 mL) 2 days before taking the study drug and during the&#xD;
                  study; and those who have special dietary requirements and cannot follow the&#xD;
                  unified diet;&#xD;
&#xD;
              14. Pregnant or lactating women;&#xD;
&#xD;
              15. Drug screening or alcohol breath test is positive.&#xD;
&#xD;
              16. Other conditions that the investigator believes the subject is not suitable.&#xD;
&#xD;
          -  CHB subjects&#xD;
&#xD;
               1. Currently suffering from serious cardiovascular, liver, kidney, digestive,&#xD;
                  nervous, blood, thyroid or mental diseases other than hepatitis B.&#xD;
&#xD;
               2. People have acute or chronic liver disease by non-HBV infection (Whether fatty&#xD;
                  liver is excluded or not is determined by the investigator).&#xD;
&#xD;
               3. Liver stiffness (LSM)&gt; 12.4 kPa(kilopascal) by noninvasive transient liver&#xD;
                  elastography (eg Fibroscan®) or recorded liver biopsy suggesting cirrhosis or&#xD;
                  extensive fibrosis within 6 months before randomization.&#xD;
&#xD;
               4. Primary liver cancer, high-risk groups of primary liver cancer or AFP(alpha&#xD;
                  fetoprotein)&gt; 50g/L;&#xD;
&#xD;
               5. Have clinically demonstrated or history of liver function decompensation,&#xD;
                  including but not limited to: hepatic encephalopathy, hepatorenal syndrome,&#xD;
                  splenomegaly, ascites, etc.;&#xD;
&#xD;
               6. Laboratory inspection:&#xD;
&#xD;
                    1. Platelet count &lt;90×10⁹/L;&#xD;
&#xD;
                    2. White blood cell count &lt;3.0×10⁹/L;&#xD;
&#xD;
                    3. Absolute value of neutrophils &lt;1.5×10⁹/L;&#xD;
&#xD;
                    4. Serum total bilirubin&gt;2×ULN;&#xD;
&#xD;
                    5. Albumin &lt;30 g/L;&#xD;
&#xD;
                    6. Creatinine clearance rate ≤60ml/min;&#xD;
&#xD;
                    7. INR(international normalized ratio)&gt;1.5;&#xD;
&#xD;
                    8. ALT&gt; 5 ULN on screening/baseline visit&#xD;
&#xD;
               7. HIV and/or syphilis antibody positive (Treponema pallidum antibody screen&#xD;
                  positive, at the investigator's discretion in conjunction with RPR results).&#xD;
&#xD;
               8. Subjects who have previously received organ/bone marrow transplantation;&#xD;
&#xD;
               9. Have used immunosuppressants, immunomodulators or cytotoxic drugs within 6 months&#xD;
                  before the study medication;&#xD;
&#xD;
              10. Suspected allergy to any ingredient in the study drug.&#xD;
&#xD;
              11. 12-ECG test have clinical significant abnormality or the QT interval (QTc) &gt; 470&#xD;
                  ms(male)/QTc)&gt; 480 ms(male) or&lt;300ms(female).&#xD;
&#xD;
              12. The average daily smoking ≥ 5 cigarettes within three months; the average daily&#xD;
                  alcohol intake in a month exceeds 15 g (15 g alcohol is equivalent to 450 mL beer&#xD;
                  or 150 mL wine or 50 mL low-alcohol);&#xD;
&#xD;
              13. Keep smoking, drinking alcohol or consuming caffeinated foods or beverages (more&#xD;
                  than 8 cups, 1 cup = 250 mL) 2 days before taking the study drug and during the&#xD;
                  study; and those who have special dietary requirements and cannot follow the&#xD;
                  unified diet;&#xD;
&#xD;
              14. Pregnant or lactating women;&#xD;
&#xD;
              15. Drug screening or alcohol breath test is positive.&#xD;
&#xD;
              16. Other conditions that the investigator believes the subject is not suitable.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Shanghai Changhai Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200433</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>July 13, 2020</study_first_submitted>
  <study_first_submitted_qc>July 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 21, 2020</study_first_posted>
  <last_update_submitted>October 19, 2021</last_update_submitted>
  <last_update_submitted_qc>October 19, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 22, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hepatitis A</mesh_term>
    <mesh_term>Hepatitis B</mesh_term>
    <mesh_term>Hepatitis B, Chronic</mesh_term>
    <mesh_term>Hepatitis</mesh_term>
    <mesh_term>Hepatitis, Chronic</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT04480294
org study id: HRS5091-101
nct id: NCT04480294
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The study is a randomized, Double-Blind, Placebo-Controlled study to evaluate the safety,
      tolerability and pharmacokinetics, pharmacodynamics and food effect of HRS5091. The study
      will be conducted in three parts sequentially:

      Part 1a will consist of 58 healthy subjects, 5 groups. The purpose of this part is to explore
      the safety, tolerability and pharmacokinetics of single doses of HRS5091 tablet in healthy
      subjects.

      Part 1b will consist of 18 healthy subjects and it is one of groups in Part 1a.The purpose of
      this part is to explore food effect of HRS5091 in healthy subjects.

      Part 1c will consist of 10 healthy subjects, 1 groups. The purpose of this part is to explore
      the safety, tolerability and pharmacokinetics of multiple doses of HRS5091 tablet in healthy
      subjects.

      Part 2 will consist of 30 CHB patients.The purpose of this part is to explore the safety,
      tolerability and pharmacokinetics, pharmacodynamics of multiple doses of HRS5091 tablet in
      naïve and treatment-discontinued chronic hepatitis B (CHB) patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Triple (Participant, Care Provider, Investigator)
measure: The incidence and severity of treatment-related
time frame: 29 DAYS for Group 1.2.4.5; 58 DAYS for Group 3; 42 DAYS for Group 6；56 DAYS for Group 7-9；
description: adverse events as assessed by CTCAE v5.0
measure: Maximum Plasma Concentration [Cmax]
time frame: 0-672 hours after each dose for Group 1-9
description: Pharmacokinetic parameters of HRS5091, main metabolite and identified major metabolites in plasma
measure: Area under the concentration time curve [AUC]
time frame: 0-672 hours after each dose for Group 1-9
description: Pharmacokinetic parameters of HRS5091, main metabolite and identified major metabolites in plasma
measure: Time to maximum plasma concentration [Tmax]
time frame: 0-672 hours after each dose for Group 1-9
description: Pharmacokinetic parameters of HRS5091, main metabolite and identified major metabolites in plasma
measure: Apparent clearance [CL/F]
time frame: 0-672 hours after each dose for Group 1-9
description: Pharmacokinetic parameters of HRS5091, main metabolite and identified major metabolites in plasma
measure: Half-time [t1/2]
time frame: 0-672 hours after each dose for Group 1-9
description: Pharmacokinetic parameters of HRS5091, main metabolite and identified major metabolites in plasma
measure: Apparent volume of distribution [Vz/F(Vd)]
time frame: 0-672 hours after each dose for Group 1-9
description: Pharmacokinetic parameters of HRS5091, main metabolite and identified major metabolites in plasma
measure: Mean retention time [MRT]
time frame: 0-672 hours after each dose for Group 1-9
description: Pharmacokinetic parameters of HRS5091, main metabolite and identified major metabolites in plasma
arm group label: Part 1a Treatment group 1
arm group type: Experimental
description: Intervention: Drug1: HRS5091, dose 1; Drug2: Placebo Healthy subjects
arm group label: Part 1a Treatment group 2
arm group type: Experimental
description: Intervention: Drug1: HRS5091, dose 2; Drug2: Placebo Healthy subjects
arm group label: Part 1a Treatment group 3
arm group type: Experimental
description: Intervention: Drug1: HRS5091, dose 3; Drug2: Placebo Healthy subjects
arm group label: Part 1a Treatment group 4
arm group type: Experimental
description: Intervention: Drug1: HRS5091, dose 4; Drug2: Placebo Healthy subjects
arm group label: Part 1a Treatment group 5
arm group type: Experimental
description: Intervention: Drug1: HRS5091, dose 5; Drug2: Placebo Healthy subjects
arm group label: Part 1b Treatment group 3
arm group type: Experimental
description: Intervention: Drug1: HRS5091, dose 3; Drug2: Placebo Healthy subjects Food effect
arm group label: Part 1c Treatment group 6
arm group type: Experimental
description: Intervention: Drug1: HRS5091, dose 3; Drug2: Placebo Healthy subjects
arm group label: Part 2 Treatment group 7
arm group type: Experimental
description: Intervention: Drug1: HRS5091, dose 3; Drug2: Placebo CHB subjects
arm group label: Part 2 Treatment group 8
arm group type: Experimental
description: Intervention: Drug1: HRS5091, dose 4; Drug2: Placebo CHB subjects
arm group label: Part 2 Treatment group 9
arm group type: Experimental
description: Intervention: Drug1: HRS5091, dose 5; Drug2: Placebo CHB subjects
intervention type: Drug
intervention name: HRS5091
description: Single dose in group 1-5
Multiple doses in group 6-9
arm group label: Part 1a Treatment group 1
arm group label: Part 1a Treatment group 2
arm group label: Part 1a Treatment group 3
arm group label: Part 1a Treatment group 4
arm group label: Part 1a Treatment group 5
arm group label: Part 1b Treatment group 3
arm group label: Part 1c Treatment group 6
arm group label: Part 2 Treatment group 7
arm group label: Part 2 Treatment group 8
arm group label: Part 2 Treatment group 9
other name: Placebo
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: China
responsible party type: Sponsor
mesh term: Hepatitis A
mesh term: Hepatitis B
mesh term: Hepatitis B, Chronic
mesh term: Hepatitis
mesh term: Hepatitis, Chronic