A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of RO7062931 in Healthy Chinese Volunteers.

  • Healthy Volunteers
Trial Status:

Completed

This trial runs in
Countries
  • Hong Kong
Trial Identifier:

NCT03505190 YP39432

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      The source of the below information is the publicly available website ClinicalTrials.gov. It has been summarised and edited into simpler language.

      The below information is taken directly from the publicly available website ClinicalTrials.gov within a week of any updates, and has not been edited.

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      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.

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