A Randomized, Sponsor-Open, Investigator-Blinded, Subject-Blinded, Placebo-Controlled, Single-Ascending Dose (SAD) and Multiple-Ascending Dose (MAD) Study to Investigate the Safety, Tolerability, and Pharmacokinetics of RO7049389 in Healthy Chinese Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Adverse Events
研究概览
简要总结
This study will assess the safety and tolerability of RO7049389 compared to placebo in single- and multiple-ascending doses in healthy Chinese participants.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Single-Ascending Dose (SAD)
Participants will receive a single dose of RO7049389.
干预措施: RO7049389 (Drug)
Multiple-Ascending Dose (MAD)
Participants will receive multiple doses of RO7049389.
干预措施: RO7049389 (Drug)
Placebo
Participants will receive either a single dose (SAD cohorts) or multiple doses (MAD cohorts) of placebo matched to RO7049389.
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants With Adverse Events
时间窗: From the date of first administered dose through 28 days after the last administered dose.
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
次要结局
- Maximum Observed Plasma Concentration (Cmax) of RO7049389(At pre-defined intervals on Day 1 (SAD) and Day 14 (MAD))
- Apparent Half-Life (T1/2) of RO7049389(At pre-defined intervals on Day 1 (SAD) and Day 14 (MAD))
- Clearance (CL/F) of RO7049389(At pre-defined intervals on Day 1 (SAD))
- Trough Plasma Concentration (Ctrough) of RO7049389(At pre-defined intervals on Day 14 (MAD))
- Time to Maximum Observed Plasma Concentration (Tmax) of RO7049389(At pre-defined intervals on Day 1 (SAD) and Day 14 (MAD))
- Area Under the Plasma Concentration vs Time Curve to Last Measurable Concentration (AUClast) of RO7049389(At pre-defined intervals on Day 1 (SAD) and Day 14 (MAD))
- Area Under the Plasma Concentration vs Time Curve Extrapolated to Infinity (AUC0-inf)(At pre-defined intervals on Day 1 (SAD) and Day 14 (MAD))
- Accumulation Index of RO7049389(At pre-defined intervals on Day 14 (MAD))
- Area Under the Concentration vs Time Curve for a Dosing Interval (AUCtau)(At pre-defined intervals on Day 14 (MAD))