A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 171 in Subjects With Obesity
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Amgen
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Number of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs)
研究概览
简要总结
To assess the safety and tolerability of AMG 171 as single or multiple doses in subjects with obesity
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Currently receiving treatment in another investigational device or drug study
- •Women of childbearing potential
- •History or evidence of a clinically significant disorder, condition or disease that would pose a risk to subject safety or interfere with the study evaluation, procedures or completion
- •Other Exclusion criteria may apply
研究组 & 干预措施
Part A
AMG 171 or placebo, 2 SAD cohorts
干预措施: AMG 171 (Drug)
Part A
AMG 171 or placebo, 2 SAD cohorts
干预措施: Placebo (Drug)
Part B
AMG 171 or placebo, 1 MAD cohort
干预措施: AMG 171 (Drug)
Part B
AMG 171 or placebo, 1 MAD cohort
干预措施: Placebo (Drug)
Part C
AMG 171 or placebo, 3 titration cohorts
干预措施: AMG 171 (Drug)
Part C
AMG 171 or placebo, 3 titration cohorts
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs)
时间窗: From first dose of IP to end of study, up to Day 207
An adverse event (AE) was any untoward medical occurrence in a clinical study participant irrespective of a causal relationship with study treatment. A serious AE (SAE) was an AE meeting at least 1 of the following serious criteria: fatal, life-threatening, required in-patient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability; congenital anomaly/birth defect; other medically important serious event. Clinically significant changes from baseline in laboratory safety tests, vital sign assessments, and 12-lead electrocardiogram assessments were included as TEAEs.
次要结局
- Maximum Observed Serum Concentration (Cmax) for AMG 171: SAD Cohorts 1 and 1b(Cohorts 1 and 1b: pre-dose Day 1; 1, 2, 4, and 8 hours post-dose Day 1, Days 2 up to Day 120)
- Cmax for AMG 171: MAD Cohorts 2 - 5(Cohort 2: pre-dose Days 1, 15, 29, 43, 57, 71; post-dose Days 5 up to 207; Cohort 3: pre-dose Days 1, 15; post-dose Days 2 up to 85; Cohort 4: pre-dose Days 1, 15, 29; post-dose Days 2 up to 113; Cohort 5: pre-dose Days 1, 8; post-dose Days 2 up to 85)
- Time of Cmax (Tmax) for AMG 171: SAD Cohorts 1 and 1b(Cohorts 1 and 1b: pre-dose Day 1; 1, 2, 4, and 8 hours post-dose Day 1, Days 2 up to Day 120)
- Tmax for AMG 171: MAD Cohorts 2 - 5(Cohort 2: pre-dose Days 1, 15, 29, 43, 57, 71; post-dose Days 5 up to 207; Cohort 3: pre-dose Days 1, 15; post-dose Days 2 up to 85; Cohort 4: pre-dose Days 1, 15, 29; post-dose Days 2 up to 113; Cohort 5: pre-dose Days 1, 8; post-dose Days 2 up to 85)
- Area Under the Plasma Concentration-time Curve (AUC) From Time 0 to Infinity (AUCinf) for AMG 171: SAD Cohorts 1 and 1b(Cohorts 1 and 1b: pre-dose Day 1; 1, 2, 4, and 8 hours post-dose Day 1, Days 2 up to Day 120)
- AUC From Time 0 to 14 Days (AUC0-14) for AMG 171: MAD Cohorts 2 - 4(Cohort 2: pre-dose Days 1, 15, 29, 43, 57, 71; post-dose Days 5 up to 207; Cohort 3: pre-dose Days 1, 15; post-dose Days 2 up to 85; Cohort 4: pre-dose Days 1, 15, 29; post-dose Days 2 up to 113)
- AUC From Time 0 to 7 Days (AUC0-7) for AMG 171: MAD Cohort 5(Cohort 5: pre-dose Days 1, 8; post-dose Days 2 up to 85)
- Number of Participants With Anti-AMG 171 Antibodies(Cohorts 1 and 1b: Day 1 pre-dose, Days 15, 29, 120; Cohort 2: Days 1, 29, 57 pre-dose, Days 15, 85, 207; Cohort 3: Days 1, 15 pre-dose, Days 29, 57, 85; Cohort 4: Days 1, 15, 29 pre-dose, Days 43, 85, 113; Cohort 5: Days 1, 8 pre-dose, Days 29, 57, 85)