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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Percentage of Participants With Adverse Events and AEs of Special Interest
研究概览
简要总结
This randomized study will evaluate the safety, tolerability and pharmacokinetics of single ascending subcutaneously administered doses of RO7062931 in healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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 -
- •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.
研究组 & 干预措施
RO7062931 0.3mg/kg
Participants will receive subcutaneously (SC) 0.3 milligram per kilogram (mg/kg) of RO7062931.
干预措施: RO7062931 (Drug)
RO7062931 0.3mg/kg
Participants will receive subcutaneously (SC) 0.3 milligram per kilogram (mg/kg) of RO7062931.
干预措施: Placebo (Drug)
RO7062931 1.0mg/kg
Participants will receive subcutaneously (SC) 1.0 milligram per kilogram (mg/kg) of RO7062931.
干预措施: RO7062931 (Drug)
RO7062931 1.0mg/kg
Participants will receive subcutaneously (SC) 1.0 milligram per kilogram (mg/kg) of RO7062931.
干预措施: Placebo (Drug)
RO7062931 2.0mg/kg
Participants will receive subcutaneously (SC) 2.0 milligram per kilogram (mg/kg) of RO7062931.
干预措施: RO7062931 (Drug)
RO7062931 2.0mg/kg
Participants will receive subcutaneously (SC) 2.0 milligram per kilogram (mg/kg) of RO7062931.
干预措施: Placebo (Drug)
RO7062931 4.0mg/kg
Participants will receive subcutaneously (SC) 4.0 milligram per kilogram (mg/kg) of RO7062931.
干预措施: RO7062931 (Drug)
RO7062931 4.0mg/kg
Participants will receive subcutaneously (SC) 4.0 milligram per kilogram (mg/kg) of RO7062931.
干预措施: Placebo (Drug)
Placebo
Participants will receive matching placebo.
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants With Adverse Events and AEs of Special Interest
时间窗: Up to 16 weeks
Adverse events of special interest for this study include the following: * Cases of an elevated ALT or AST in combination with either an elevated bilirubin or clinical jaundice * Suspected transmission of an infectious agent by the study drug * Severe injection site reactions * Renal adverse events
Percentage of Participants With Marked Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation and Urinalysis Test Results
时间窗: Baseline, Day 2, 8, 15, 29, 85
Marked reference range has been predefined for each laboratory parameter. The marked reference range is broader than the standard reference range. Values falling outside the marked reference range that also represent a defined change from baseline will be considered marked laboratory abnormalities (i.e., potentially clinically relevant). If a baseline value is not available for a study subject, the midpoint of the standard reference range will be used as the study participant baseline value for the purposes of determining marked laboratory abnormalities.
Percentage of Participants With Electrocardiogram (ECG) Abnormalities
时间窗: Baseline; pre-dose, 1 hour (h), 4, 8, 12h post-dose Day 1, 24h post-dose Day 2, 8, 15, 29, 85
Table entries provide the percentage of Participants with a during treatment assessment abnormality in the direction specified regardless of this abnormality at baseline. Abnormalities reported in Participants with missing baseline values are included. Baseline is the Participant's last observation prior to initiation of study drug.
Percentage of Participants With T-wave Abnormalities
时间窗: Baseline; pre-dose, 1 hour (h), 4, 8, 12h post-dose Day 1, 24h post-dose Day 2, 8, 15, 29, 85
Table entries provide the percentage of Participants with a during treatment assessment abnormality in the direction specified regardless of this abnormality at baseline. Abnormalities reported in Participants with missing baseline values are included. Baseline is the Participant's last observation prior to initiation of study drug.
Percentage of Participants With U-wave Abnormalities
时间窗: Baseline; pre-dose, 1 hour (h), 4, 8, 12h post-dose Day 1, 24h post-dose Day 2, 8, 15, 29, 85
Table entries provide the percentage of Participants with a during treatment assessment abnormality in the direction specified regardless of this abnormality at baseline. Abnormalities reported in Participants with missing baseline values are included. Baseline is the Participant's last observation prior to initiation of study drug.
次要结局
- Cumulative Amount of RO7062931 Excreted in Urine (Ae)((0-4), (4-8), (8-12), (12-24)h post-dose Day 1)
- Maximum Plasma Concentration (Cmax) for RO7062931(Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18h post-dose Day 1, 24, 30, 36h post-dose Day 2, Day 3, 4, 5, 6, 8)
- Time to Reach Maximum Plasma Concentration (Tmax) for RO7062931(Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18h post-dose Day 1, 24, 30, 36h post-dose Day 2, Day 3, 4, 5, 6, 8)
- Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) for RO7062931(Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18h post-dose Day 1, 24, 30, 36h post-dose Day 2, Day 3, 4, 5, 6, 8)
- Area Under the Plasma Concentration-Time Curve From Time Zero Until the Last Quantifiable Time-Point (AUC0-last) for RO7062931(Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18h post-dose Day 1, 24, 30, 36h post-dose Day 2, Day 3, 4, 5, 6, 8)
- Apparent Volume of Distribution (Vz/F) for RO7062931(Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18h post-dose Day 1, 24, 30, 36h post-dose Day 2, Day 3, 4, 5, 6, 8)
- Fraction of Cumulative Amount of RO7062931 Excreted in the Urine Over Total Dose (Fe)(0-24h h post-dose Day 1)
- Terminal Elimination Half-Life (t1/2) for RO7062931(Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18h post-dose Day 1, 24, 30, 36h post-dose Day 2, Day 3, 4, 5, 6, 8)
- Apparent Clearance (CL/F) for RO7062931(Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18h post-dose Day 1, 24, 30, 36h post-dose Day 2, Day 3, 4, 5, 6, 8)