A Study to Assess the Safety and Tolerability of Single and Multiple Ascending Doses of Oral RO7020531 in Chinese Healthy Participants.
Condition: Healthy Participants
Intervention: RO7020531; Placebo
Intervention description: 4 SAD Cohorts with individual dosages of 40, 100, 140 and 170 mg hard capsules and 3 MAD Cohorts with dosages of 100 and 150mg hard capsules, will be administered orally as per the dosing schedules described above.; Placebo hard capsules will be administered orally as per the dosing schedules described above.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Enrollment: 70.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      To evaluate the safety and tolerability of single and multiple ascending doses of oral
      RO7020531 in Chinese healthy participants.
    

Eligibility criteria:

        Inclusion Criteria

          -  Chinese healthy male and female participants. Healthy status is defined by absence of
             evidence of any active or chronic disease following a detailed medical and surgical
             history, a complete physical examination including vital signs, 12-lead ECG,
             hematology, blood chemistry, and urinalysis.

          -  A Body Mass Index (BMI) of 19 to less than 28 kg/m2 and a body weight of at least 45
             kg.

          -  Negative anti-nuclear antibody (ANA) test; or positive with dilutions not greater than
             1:40 and with no associated history or symptoms of potential connective tissue disease
             or other immune-mediated diseases.

          -  Women of childbearing potential: agreement to remain abstinent (refrain from
             heterosexual intercourse) or use contraceptive methods.

          -  Men: agreement to remain abstinent (refrain from heterosexual intercourse) or use
             contraceptive measures and refrain from donating sperm.

          -  Negative pregnancy test on Day -1 for female participants.

          -  Non-smokers, or use of < 10 cigarettes (or equivalent nicotine-containing product) per
             day.

        Exclusion Criteria

          -  Pregnant (positive pregnancy test) or lactating women, and male partners of women who
             are pregnant or lactating.

          -  History of immunologically mediated disease (e.g., inflammatory bowel disease,
             idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia,
             scleroderma, severe psoriasis, rheumatoid arthritis, multiple sclerosis, or any other
             autoimmune disease).

          -  History or symptoms of any clinically significant disease including (but not limited
             to), neurological, cardiovascular, endocrine, respiratory, hepatic, ocular, or renal
             disorder (as per Investigator's judgment).

          -  Personal or family history of congenital long QT syndrome or sudden cardiac death.

          -  Evidence of an active or suspected cancer or a history of malignancy, where in the
             Investigator's opinion, there is a risk of recurrence.

          -  History of having received or currently receiving any systemic anti-neoplastic
             (including radiation) or immune-modulatory treatment (including systemic oral or
             inhaled corticosteroids, IFN or PEG-IFN) within 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. Eye drop-containing and infrequent inhaled corticosteroids are permissible
             up to 4 weeks prior to the first dose of study drug.

          -  History of clinically significant thyroid disease; also, subjects with clinically
             significant elevated thyroid-stimulating hormone (TSH) concentrations at Screening.

          -  Any confirmed clinically significant allergic reactions (anaphylaxis) against any
             drug, or multiple drug allergies (non-active hay fever is acceptable).

          -  Abnormal renal function.

          -  Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) values at Screening
             above ULN and judged clinically significant by the Investigator.

          -  Positive results for anti-mitochondrial antibody (AMA), anti-smooth muscle antibody
             (ASMA) or thyroid peroxidase antibody.

          -  Positive hepatitis A IgM antibody (HAV Ab IgM), hepatitis B surface antigen (HBsAg),
             hepatitis C antibody (HCV Ab), or positive for human immunodeficiency virus (HIV) at
             Screening.