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

Roche

Status and phase: Completed; Phase 1

Conditions: Healthy Participants

Treatments: Drug: Placebo; Drug: RO7062931

Study type: Interventional

Funder types: Industry

Identifiers

NCT03505190

YP39432

Details and patient eligibility

About

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

Enrollment: 41 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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41 participants in 5 patient groups, including a placebo group

RO7062931 0.3mg/kg

Experimental group

Description:

Participants will receive subcutaneously (SC) 0.3 milligram per kilogram (mg/kg) of RO7062931.

Treatment:

Drug: Placebo

Drug: RO7062931

RO7062931 1.0mg/kg

Experimental group

Description:

Participants will receive subcutaneously (SC) 1.0 milligram per kilogram (mg/kg) of RO7062931.

Treatment:

Drug: Placebo

Drug: RO7062931

RO7062931 2.0mg/kg

Experimental group

Description:

Participants will receive subcutaneously (SC) 2.0 milligram per kilogram (mg/kg) of RO7062931.

Treatment:

Drug: Placebo

Drug: RO7062931

RO7062931 4.0mg/kg

Experimental group

Description:

Participants will receive subcutaneously (SC) 4.0 milligram per kilogram (mg/kg) of RO7062931.

Treatment:

Drug: Placebo

Drug: RO7062931

Placebo

Placebo Comparator group

Description:

Participants will receive matching placebo.

Treatment:

Drug: Placebo