An Investigator- and Participant-Blind, Randomized, Placebo-Controlled, Parallel-Group, Phase I Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of Orally Administered RO7795081 in Otherwise Healthy Chinese Adult Participants With Obesity or Overweight
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Incidence of Abnormal Vital Signs
研究概览
简要总结
This is an investigator- and participant-blind, randomized, placebo-controlled, parallel-group, Phase I study evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple doses of orally administered RO7795081 in otherwise healthy Chinese adult participants with obesity or overweight.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants who are healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring
- •Participants who are ethnically Chinese and living in mainland China
- •Body mass index (BMI) ≥24 kg/m^2 at screening
- •Agreement to adhere to the contraception requirements
排除标准
- •Any medical condition or disease that could be expected to progress, recur, or change to such an extent that it could bias the assessment of the clinical or mental status of the participant to a significant degree or put the participant at special risk in the opinion of the Investigator. Such conditions may include clinically significantly impaired endocrine, thyroid, hepatic, respiratory, or renal function for any reason, unstable diabetes mellitus and insulin dependent diabetes mellitus, clinically significant cardiovascular disease, pheochromocytoma, or history of any psychotic mental illness.
研究组 & 干预措施
RO7795081
干预措施: RO7795081 (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of Abnormal Vital Signs
时间窗: Baseline to Safety Follow-Up (26 weeks)
Incidence of Abnormal Electrocardiogram (ECG) Results
时间窗: Baseline to Safety Follow-Up (26 weeks)
Incidence, Severity, and Causal Relationship to Treatment of Adverse Events
时间窗: Baseline to Safety Follow-Up (26 weeks)
Incidence of Abnormal Clinical Laboratory Test Findings
时间窗: Baseline to Safety Follow-Up (26 weeks)
Incidence of Abnormal Psychiatry Parameters
时间窗: Baseline to Safety Follow-Up (26 weeks)
Participants with psychiatric abnormalities include those with a Patient Health Questionnaire-9 (PHQ-9) score of ≥15 at any assessment, any suicidal behavior, or any suicidal ideation of Type 4 (active suicidal ideation with some intent to act without a specific plan) or Type 5 (active suicidal ideation with a specific plan and intent) on any Columbia-Suicide Severity Rating Scale (C-SSRS) assessment.
次要结局
- Plasma Concentration of RO7795081(At prespecified timepoints on Weeks 8, 14, 17, 19, 21, and 22)
- Maximum Plasma Concentration Observed (Cmax) of RO7795081(At prespecified timepoints on Weeks 8, 14, and 22)
- Time to Cmax (Tmax) of RO7795081(At prespecified timepoints on Weeks 8, 14, and 22)
- Area Under the Concentration-Time Curve from Time 0 to the Last Measurable Concentration (AUClast) of RO7795081(At prespecified timepoints on Weeks 8, 14, and 22)