A Phase 1 Study in Healthy Subjects to Evaluate the Relative Bioavailability of ABBV-154
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- The Area Under the Plasma Concentration-Time Curve (AUC) from Time 0 to Infinity (AUC∞)
研究概览
简要总结
This study will assess how safe ABBV-154 is and how ABBV-154 moves through the body of adult healthy participants. Adverse Events will be assessed.
ABBV-154 is an investigational drug being developed for potential treatment of immune-mediated inflammatory diseases. Participants are randomly assigned to one of the 2 treatment groups. Approximately 40 adult healthy volunteers will be enrolled in 2 sites in the United States.
All participants will receive ABBV-154 as subcutaneous injections with one of the 2 different formulations.
There may be higher burden for participants in this trial. Participants will be confined for 9 days. Adverse Events and blood tests will be performed.
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
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body Mass Index (BMI) is ≥ 18.0 to ≤ 29.9 kg/m2 after rounding to the nearest tenth at screening and upon initial confinement.
排除标准
- •Participant using any medications, vitamins and/or herbal supplements, within the 2 week period or 5 half-lives (whichever is longer) prior to study drug administration.
- •History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma), renal, hepatic, gastrointestinal, hematologic, demyelinating disease (including myelitis) or neurologic symptoms suggestive of demyelinating disease, glaucoma, psychiatric disease or disorder, or any uncontrolled medical illness.
- •Prior exposure to similar biologic therapies.
研究组 & 干预措施
ABBV-154 Dose A
Participants will receive subcutaneous dose of ABBV-154 Dose Formulation A.
干预措施: ABBV-154 Dose Formulation A (Drug)
ABBV-154 Dose B
Participants will receive subcutaneous dose of ABBV-154 Dose Formulation B.
干预措施: ABBV-154 Dose Formulation B (Drug)
结局指标
主要结局
The Area Under the Plasma Concentration-Time Curve (AUC) from Time 0 to Infinity (AUC∞)
时间窗: Approximately up to 58 days
The Area Under the Plasma Concentration-Time Curve (AUC) from Time 0 to Infinity (AUC∞)
Number of Participants with Adverse Events
时间窗: Approximately up to 72 days
An adverse event (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. The investigator assesses the relationship of each event to the use of study.
Time to Maximum Observed Plasma Concentration (Tmax)
时间窗: Approximately up to 58 days
Time to Maximum Observed Plasma Concentration (Tmax)
Apparent Terminal Phase Elimination Rate Constant (β)
时间窗: Approximately up to 58 days
Apparent Terminal Phase Elimination Rate Constant (β)
The Terminal Phase Elimination Half-Life (t1/2)
时间窗: Approximately up to 58 days
The Terminal Phase Elimination Half-Life (t1/2)
Maximum Observed Plasma Concentration (Cmax)
时间窗: Approximately up to 58 days
Maximum Observed Plasma Concentration (Cmax)
The Area Under the Plasma Concentration-Time Curve (AUC) from Time 0 to Time of the Last Measurable Concentration (AUCt)
时间窗: Approximately up to 58 days
The Area Under the Plasma Concentration-Time Curve (AUC) from Time 0 to Time of the Last Measurable Concentration (AUCt)
次要结局
未报告次要终点