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

NCT ID: NCT03505190

Last Updated: 2020-08-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-03
• Study Completion Date: 2019-07-05

Brief Summary

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

Conditions

Healthy Participants

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

RO7062931 0.3mg/kg

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

Group Type: EXPERIMENTAL

RO7062931

Intervention Type: DRUG

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.

Placebo

Intervention Type: DRUG

Matching placebo will be administered subcutaneously (SC).

RO7062931 1.0mg/kg

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

Group Type: EXPERIMENTAL

RO7062931

Intervention Type: DRUG

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.

Placebo

Intervention Type: DRUG

Matching placebo will be administered subcutaneously (SC).

RO7062931 2.0mg/kg

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

Group Type: EXPERIMENTAL

RO7062931

Intervention Type: DRUG

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.

Placebo

Intervention Type: DRUG

Matching placebo will be administered subcutaneously (SC).

RO7062931 4.0mg/kg

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

Group Type: EXPERIMENTAL

RO7062931

Intervention Type: DRUG

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.

Placebo

Intervention Type: DRUG

Matching placebo will be administered subcutaneously (SC).

Placebo

Participants will receive matching placebo.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matching placebo will be administered subcutaneously (SC).

Interventions

RO7062931

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.

Intervention Type: DRUG

Placebo

Matching placebo will be administered subcutaneously (SC).

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Queen Mary Hospital

Hong Kong, , Hong Kong

Prince of Wales Hospital

Shatin, New Territories, , Hong Kong

Countries

Hong Kong

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

YP39432

Identifier Type: -

Identifier Source: org_study_id