A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Ascending, Single- and Multiple-Oral-Dose, Safety, Tolerability, and Pharmacokinetic Study of GDC-3280 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 8
- 主要终点
- Number of participants experiencing an adverse event
研究概览
简要总结
This is a Phase 1, Randomized, Double-Blind, Placebo-Controlled, Ascending, Single- and Multiple-Oral Dose, Safety, Tolerability, and Pharmacokinetic Study of GDC-3280 in Healthy Subjects.
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
- •Is male or female, using highly effective contraception
- •Has a body mass index (BMI) 18.0 to 30.0 kg/m2, inclusive
- •Is in good general health
- •Having signed informed consent, is willing and able to comply with requirements of the study
排除标准
- •Does not satisfy all screening criteria per protocol
- •Is employed by or related to any personnel involved in the trial
- •Has any history or condition that per protocol or in the opinion of the investigator could compromise the participant's safety or analysis of results
研究组 & 干预措施
Part A: GDC-3280
Participants in multiple cohorts and treatment periods will receive single doses of GDC-3280 under fed/fasting conditions.
干预措施: GDC-3280 (Drug)
Part A: Placebo
Participants in multiple cohorts and treatment periods will receive single doses of placebo under fed/fasting conditions.
干预措施: Placebo (Drug)
Part B: GCD-3280
Participants in different cohorts will receive GDC-3280 in multiple ascending doses under fed/fasting conditions.\n
干预措施: GDC-3280 (Drug)
Part B: Placebo
Participants in different cohorts will receive placebo in multiple ascending doses under fed/fasting conditions.\n
干预措施: Placebo (Drug)
结局指标
主要结局
Number of participants experiencing an adverse event
时间窗: Up to approximately 6 months
次要结局
- Total serum clearance for GDC-3280(Up to 4 days)
- Volume of distribution for GDC-3280(Up to 4 days)
- Maximum concentration (Cmax) for GDC-3280(Up to 4 days)
- Time to Cmax (Tmax) for GDC-3280(Up to 4 days)
- Elimination half-life for GDC-3280(Up to 4 days)
- Serum GDC-3280 concentration-time data by dosing group(Up to 4 days)