A Randomized Double-Blind Placebo-Controlled Study to Evaluate the Safety Tolerability Pharmacokinetics of AHB-137 with Single Ascending Doses and Multiple Doses in Healthy Volunteers and Initial Efficacy in Chronic Hepatitis B Patients

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Chronic Hepatitis B
  • Age: Between 18 Year(s) - 65 Year(s)
  • Gender: Male or Female
  • Other Inclusion Criteria:
      Healthy participants:
    1. Body Mass Index (BMI) between 19 to 35 kg/m2 (inclusive) and body weight equal to or over 45 kg.
    2. Healthy female volunteers cannot be pregnant at the time of recruiting and during the study. Healthy female volunteers with childbearing potential must remain abstinent or use two methods of contraception with their partner, one of which must be a barrier method (e.g. condom), for the duration of the study and for at least 180 days after the last dose of study-drug.
    3. For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm.
    4. Did not receive any vaccines within 3 month and no plan to take any vaccines during the whole study period, including follow-up phase.
      CHB patients:
    1. CHB patients who have documented chronic HBV infection equal to or above 6 months prior to screening. Otherwise, CHB patients need to be HBsAg positive and IgM HBcAb negative.
    2. Females: Non-pregnant and non-lactating; surgically sterile (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy), post-menopausal, or, if engaged in sexual relations of child-bearing potential, patient is using an acceptable contraceptive method from the time of signing the informed consent form until at least 180 days after the last dose of study drug.
    3. Males: Surgically sterile or if engaged in sexual relations with a female of childbearing potential, patient is utilizing an acceptable contraceptive method during treatment with study drug for at least 180 days after the last dose of study drug.
    4. Participants receiving stable nucleos(t)ide analogue (NA) therapy are expected to continue NA therapy during the trial; participants not receiving NA therapy at the time of trial entry are expected to continue without NA during the trial and to start NA therapy at least 30 days after the last dose.
    5. Did not receive any vaccines within 3 months and no plan to take any vaccines during the whole study period, including follow-up phase.

You may not be eligible for this study if the following are true:

    1. Pregnant (positive pregnancy test) or lactating women. Male participants without using proper contraceptives (e.g. condom) with partners who are pregnant or lactating.
    2. History or symptoms of any clinically significant gastrointestinal, renal, hepatic, bronchopulmonary, neurological, psychiatric, cardio-vascular, endocrinological, hematological or allergic disease, metabolic disorder, cancer or cirrhosis.
    3. Personal history of congenital long QT syndrome or family history of sudden cardiac death.
    4. History of having received or currently receiving any systemic anti-neoplastic (including radiation) or immune-modulatory treatment (including systemic oral) = 6 months prior to the first dose of study-drug or the expectation that such treatment will be needed at any time during the study.
    5. Participants who have had significant acute infection, e.g., influenza, local infection, acute gastrointestinal symptoms or any other clinically significant illness within two weeks of dose administration.
    6. Any confirmed significant allergic reactions (urticaria or anaphylaxis) against any drug, or multiple drug allergies (non-active hay fever is acceptable).
    7. Confirmed (based on the average of three separate resting blood pressure measurements one minute apart, properly measured with well-maintained equipment, after at least 5 minutes rest) systolic blood pressure (BP) greater than 140 or less than 90 mmHg, or diastolic BP greater than 90 or less than 50 mmHg at screening.
    8. Positive test at screening of any of the following: hepatitis A virus (HAV IgM Ab), hepatitis B virus (HBsAg), hepatitis C virus (HCV RNA or HCV Ab), human immunodeficiency virus 1 and 2 (HIV Ab), or TP-Ab.
    9. History of bleeding diathesis or coagulopathy.
    10. Receipt of another investigational drug or device within 30 days of dosing or 5 half-lives, whichever is longer.
    11. Donation or loss of blood 100 to 499 mL within 30 days of screening or over 500 mL within 3 months prior to screening.
    12. Positive test for drugs of abuse (including recreational drugs).
    13. Any suspicion or history of drug and/or alcohol abuse within the last year.
    14. History (within 3 months of screening) of alcohol consumption exceeding 14 units per week for females and more than 21 units per week for males (1 unit = 10 ml of pure alcohol).
    15. Use of > one pack cigarettes or equivalent nicotine-containing product per day.
    16. Taking any prescribed or over-the-counter medications (including vitamins or herbal remedies) within 2 weeks or 7 days, respectively, relative to first dosing or within 5 times the elimination half-life of the medication prior to first dosing (whichever is longer). Occasional use is allowed.
    17. Participants under judicial supervision, guardianship or curatorship.
    18. Significant change in meal and exercise within 2 weeks of screening.

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