Select Your Region
Americas
Europe
Africa
Global
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of RO7062931 in Healthy Chinese Volunteers.
- Healthy Volunteers
Please note that the recruitment status of the trial at your site may differ from the overall study status because some study sites may recruit earlier than others.
Trial Status:
Completed
This trial runs in
Country
- Hong Kong
Trial Identifier:
NCT03505190 YP39432
Trial Summary
This randomized study will evaluate the safety, tolerability and pharmacokinetics of single ascending subcutaneously administered doses of RO7062931 in healthy volunteers.
Hoffmann-La Roche
Sponsor
Phase 1
Phase
NCT03505190, YP39432
Trial Identifier
RO7062931, Placebo
Treatments
Healthy Participants
Condition
Official Title
A Randomized, Sponsor-Open, Investigator-Blind, Subject-Blind, Placebo-Controlled, Single Ascending Dose, to Investigate the Safety, Tolerability and Pharmacokinetics of RO7062931 Following Subcutaneously Administration in Healthy Chinese Volunteers
Eligibility Criteria
All
Gender
≥ 18 Years & ≤ 60 Years
Age
Accepts Healthy Volunteers
Healthy Volunteers
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.
For the latest version of this information please go to www.forpatients.roche.com