A Phase 1, Randomized, Double-blind, Placebo-controlled, Integrated Single Ascending Dose, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 691 in Healthy Participants and Participants With Mild-to-Moderate Asthma
概览
- 阶段
- 1 期
- 干预措施
- AMG 691
- 疾病 / 适应症
- 未指定
- 发起方
- Amgen
- 入组人数
- 124
- 试验地点
- 34
- 主要终点
- Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
- 状态
- 招募中
- 最后更新
- 上个月
概览
简要总结
The main objective of this study is to assess the safety and tolerability of AMG 691 as single doses (healthy participants only) and multiple doses in healthy participants and participants with mild-to-moderate asthma.
研究者
入排标准
入选标准
- •Inclusion Part A and B
- •Participants must be capable of giving informed consent and have provided informed consent.
- •Participants must be 18 to 65, inclusive at time of signing of informed consent.
- •Participants must have a Body Mass Index between 18.0 to 30 kg/m\^2 and total body weight ≥ 40 kg at screening.
- •Participants must be overtly healthy as determined by the investigator based on medical evaluation and study screening procedures.
- •Female participants must be of non-childbearing potential.
- •Inclusion Part C
- •Participants must be capable of giving informed consent and have provided informed consent.
- •Participants must be 18 to 70, inclusive at time of signing of informed consent.
- •Body mass index between 18.0 to 35 kg/m\^2 and total body weight ≥ 40 kg at screening.
排除标准
- 未提供
研究组 & 干预措施
Part A: Single Ascending Dose (SAD)
Healthy participants will be randomized in a 3:1 ratio to receive either AMG 691 or placebo.
干预措施: AMG 691
Part A: Single Ascending Dose (SAD)
Healthy participants will be randomized in a 3:1 ratio to receive either AMG 691 or placebo.
干预措施: Placebo
Part B: Multiple Ascending Dose (MAD)
Healthy participants will be randomized in a 3:1 ratio to receive either AMG 691 or placebo.
干预措施: AMG 691
Part B: Multiple Ascending Dose (MAD)
Healthy participants will be randomized in a 3:1 ratio to receive either AMG 691 or placebo.
干预措施: Placebo
Part C: Multiple Dose
Participants with mild-to-moderate asthma will be randomized in a 2:1 ratio to receive either AMG 691 or placebo.
干预措施: AMG 691
Part C: Multiple Dose
Participants with mild-to-moderate asthma will be randomized in a 2:1 ratio to receive either AMG 691 or placebo.
干预措施: Placebo
结局指标
主要结局
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
时间窗: Up to approximately 11 months
An adverse event (AE) is any untoward medical occurrence in a clinical study participant irrespective of a causal relationship with the study treatment. TEAEs are any event that occurred after the participant received study treatment. Serious AEs (SAEs) are defined as any untoward medical occurrence that, meet at least 1 of the following serious criteria: Immediately life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect. Includes AEs of interest (AEOI), and AEs leading to discontinuation.
次要结局
- Maximum Concentration (Cmax) of AMG 691(Up to approximately 11 months)
- Area Under the Curve (AUC) of AMG 691(Up to approximately 11 months)