A Double-Blind Single-Ascending Dose (SAD) and Multiple-Ascending Dose (MAD) Study to Investigate the Safety, Tolerability, and Pharmacokinetics of RO7049389 in Healthy Chinese Participants
Condition: Hepatitis B Virus
MeSH terms: Hepatitis B
Intervention: RO7049389; Placebo
Intervention description: RO7049389 will be administered orally either as a single dose (SAD) or as multiple doses defined by the SAD portion of the study (MAD).; Placebo will be administered orally at a dose and frequency matched to RO7049389.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will assess the safety and tolerability of RO7049389 compared to placebo in
      single- and multiple-ascending doses in healthy Chinese participants.
    

Eligibility criteria:

        Inclusion Criteria

          -  Chinese healthy male and female subjects, 18 to 60 years of age, inclusive.

          -  A Body Mass Index (BMI) of between 19 to 27 kg/m2 inclusive, and a body weight of at
             least 45 kg.

          -  Women should be of non-childbearing potential. Female subjects must be either
             surgically sterile (by means of hysterectomy and/or bilateral oophorectomy) or
             post-menopausal for at least one year (defined as amenorrhea >/=12 consecutive months
             without another cause, and confirmed by follicle stimulating hormone level >35
             mIU/mL).

          -  For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use
             contraceptive measures, and agreement to refrain from donating sperm

        Exclusion Criteria

          -  Pregnant (positive pregnancy test) or lactating women, and male subjects with partners
             who are pregnant or lactating.

          -  History or symptoms of any clinically significant gastrointestinal, renal, hepatic,
             broncho-pulmonary, neurological, psychiatric, cardio-vascular, endocrinological,
             hematological or allergic disease, metabolic disorder, cancer or cirrhosis.

          -  Personal history of congenital long QT syndrome or family history of sudden death.

          -  History of Gilbert's syndrome.

          -  History of having received or currently receiving any systemic anti-neoplastic
             (including radiation) or immune-modulatory treatment (including systemic oral or
             inhaled corticosteroids) </=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.

          -  Subjects 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.

          -  Any confirmed significant allergic reactions (urticaria or anaphylaxis) against any
             drug, or multiple drug allergies (non-active hay fever is acceptable).

          -  Electrocardiogram (ECG) with QRS and/or T-wave judged to be unfavorable for a
             consistently accurate QT measurement (e.g., neuromuscular artifact that cannot be
             readily eliminated, arrhythmias, indistinct QTS onset, low amplitude T-wave, merged T-
             and U waves, prominent U-waves)

          -  Creatinine clearance (CrCl) </=70 mL/min (using the Cockcroft-Gault formula)

          -  Positive test at screening of any of the following: hepatitis A (HAV IgM Ab),
             hepatitis B (HBsAg), hepatitis C (HCV RNA or HCV Ab) or human immunodeficiency virus 1
             and 2 (HIV Ab).

          -  Participation in an investigational drug or device study within 90 days prior to
             screening or more than 4 times per year.

          -  Donation or loss of blood over 500 mL within 3 months prior to screening.

          -  Any suspicion or history of drug and/or alcohol abuse within the last year.

          -  History (within 3 months of screening) of alcohol consumption exceeding two standard
             drinks per day on average (1 standard drink = 10 grams of alcohol). Alcohol
             consumption will be prohibited at least 48 hours before screening, 48 hours before and
             48 hours after each dose, and 48 hours before each scheduled visit.

          -  Use of >5 cigarettes or equivalent nicotine-containing product per day.

          -  Taking any prescribed or over-the-counter medications (including vitamins or herbal
             remedies) within 2 weeks of first dosing or within 5 times the elimination half-life
             of the medication prior to first dosing (whichever is longer). Occasional
             acetaminophen/paracetamol is allowed.

          -  Subjects under judicial supervision, guardianship or curatorship.