A Phase 1 Pharmacokinetic Study in Healthy Adult Volunteers to Evaluate the Bioavailability of ABBV-8736 Following Subcutaneous Administration Relative to Intravenous Administration
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
- Time to Maximum Observed Serum Concentration (Tmax) of ABBV-8736
研究概览
简要总结
The purpose of this study is to assess the pharmacokinetics (PK), bioavailability, immunogenicity, safety, and tolerability of ABBV-8736 following subcutaneous (SC) administration relative to intravenous (IV) administration.
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 <= 32.0 kg/m2 after rounding to the tenths decimal. BMI is calculated as weight in kg divided by the square of height measured in meters.
- •Body weight >= 35 kg.
- •A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead electrocardiogram (ECG).
排除标准
- •Participant requires any over-the-counter and/or prescription medication, vitamins, and/or herbal supplements, on a regular basis.
- •Participant uses any medications, vitamins and/or herbal supplements within the 14-day period prior to study treatment administration.
- •Participant has received any treatment by injection within 30 days or within a period defined by 5 half-lives, whichever is longer, prior to study treatment administration.
- •Participant has prior exposure to a Triggering Receptor Expressed on Myeloid Cells 1 (TREM1) agent.
研究组 & 干预措施
Arm 1: Intravenous (IV) ABBV-8736
Participants will receive IV ABBV-8736 on Day 1.
干预措施: ABBV-8736 (Drug)
Arm 2: Subcutaneous (SC) ABBV-8736
Participants will receive SC ABBV-8736 on Day 1.
干预措施: ABBV-8736 (Drug)
结局指标
主要结局
Time to Maximum Observed Serum Concentration (Tmax) of ABBV-8736
时间窗: Up to At Least 3 Months
Tmax of ABBV-8736.
Number of Participants with Adverse Events (AEs)
时间窗: Up to At Least 3 Months
An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Maximum Observed Serum Concentration (Cmax) of ABBV-8736
时间窗: Up to At Least 3 Months
Cmax of ABBV-8736.
Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to the Time Last (AUClast) of ABBV-8736
时间窗: Up to At Least 3 Months
AUClast of ABBV-8736.
AUC From Time 0 to the Time Infinity (AUCinf) of ABBV-8736
时间窗: Up to At Least 3 Months
AUCinf of ABBV-8736.
Terminal Phase Elimination Rate Constant (β) of ABBV-8736
时间窗: Up to At Least 3 Months
β of ABBV-8736.
Terminal Elimination Half-Life (t1/2) of ABBV-8736
时间窗: Up to At Least 3 Months
t1/2 of ABBV-8736.
Apparent Clearance of the Analyte in Serum (CL) of ABBV-8736
时间窗: Up to At Least 3 Months
CL of ABBV-8736.
次要结局
未报告次要终点