A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of RO7062931 in Healthy Chinese Volunteers.
Condition: Healthy Participants
Intervention: RO7062931; Placebo
Intervention description: RO7062931 will be administered SC in single ascending doses with starting of 0.3 mg/kg and subsequent doses of 1.0 mg/kg, 2.0 mg/kg and 3.0 mg/kg, respectively. Additional (optional) dose of 4.0 mg/kg may be administered based on safety, tolerability and PK data.; Matching placebo will be administered subcutaneously (SC).
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Enrollment: 41.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This randomized study will evaluate the safety, tolerability and pharmacokinetics of single
      ascending subcutaneously administered doses of RO7062931 in healthy volunteers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Chinese healthy male and female (of non-childbearing potential) volunteers.

          -  A Body Mass Index (BMI) between 19 to 27 kilogram per square meter (kg/m2) inclusive
             and a body weight of at least 45 kg.

          -  Women should be of non-childbearing potential. These include those who have undergone
             surgical sterilization (removal of ovaries and/or uterus) or are post-menopausal.

          -  Men must agree to remain abstinent (refrain from heterosexual intercourse) or use
             contraceptive measures during treatment and up to 105 days after the last dose of
             RO7062931, and agree to refrain from donating sperm during this same period.

          -  Non-smoker (nor tobacco containing products) for at least 90 days prior to dosing on
             Day 1 and agree to remain as non-smoker during the study.

        Exclusion Criteria:

          -  History of drug or alcohol abuse or dependence in previous 6 months.

          -  Positive urine drug and alcohol screen or positive cotinine test at Screening or Day
             -1.

          -  Positive result on hepatitis B (HBV), hepatitis C (HCV), or human immunodeficiency
             virus (HIV)-1 and -2 at Screening.

          -  Confirmed blood pressure or resting pulse rate outside of accepted ranges.

          -  Participation in an investigational drug or device study within 90 days prior to
             screening.

          -  Donation of blood over 500 milliliters (mL) within three months prior to screening.

          -  Any major illness within the one month, or any febrile illness within two weeks
             preceding the screening visit.

          -  Alcohol consumption of more than 2 standard drinks per day on average.

          -  Screening or baseline ECG evidence of atrial fibrillation, atrial flutter, complete
             right or left bundle branch block, Wolff-Parkinson-White syndrome, or cardiac
             pacemaker.

          -  Any out of range findings in liver function tests, INR and renal function tests or any
             clinically significant abnormalities (as judged by the Investigator) in the physical
             examination and in the remaining laboratory test results (including hepatic and renal
             panels, complete blood count, chemistry panel and urinalysis) at Screening or on
             Day-1.