A Phase 1, Double-blind, Placebo-Controlled, First-in-Human Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses ofABBV-1162 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- AbbVie
- 入组人数
- 40
- 主要终点
- Number of Participants Experiencing Adverse Events
研究概览
简要总结
The goal of this study is to evaluate the safety, tolerability, and pharmacokinetics of ABBV-1162 in healthy adults.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy individuals in general good health.
- •Blood pressure and heart rate measurements within specified ranges: systolic blood pressure < 140 mmHg, diastolic blood pressure < 90 mmHg, heart rate <= 100 bpm and >= 55 bpm, absence of orthostatic hypotension.
排除标准
- 未提供
研究组 & 干预措施
ABBV-1162
Participants will receive a single oral dose of ABBV-1162.
干预措施: ABBV-1162 (Drug)
Placebo
Participants will receive a single oral dose of placebo.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants Experiencing Adverse Events
时间窗: Up to approximately 31 days
An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Maximum Plasma Concentration (Cmax) of ABBV-1162
时间窗: Up to approximately 3 days
Cmax of ABBV-1162
Time to Cmax (Tmax) of ABBV-1162
时间窗: Up to approximately 3 days
Time to Cmax (Tmax) of ABBV-1162
Terminal Phase Elimination Rate Constant (Beta) of ABBV-1162
时间窗: Up to approximately 3 days
Beta of ABBV-1162
Terminal Phase Elimination Half-Life (t1/2) of ABBV-1162
时间窗: Up to approximately 3 days
t1/2 of ABBV-1162
Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to the Time of the Last Measurable Concentration (AUCt) of ABBV-1162
时间窗: Up to approximately 3 days
AUCt of ABBV-1162
AUC From Time 0 to the Time Infinity (AUCinf) of ABBV-1162
时间窗: Up to approximately 3 days
AUCinf of ABBV-1162
次要结局
未报告次要终点