A Phase 1, Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of ABBV-8736 After Multiple Ascending Doses in Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Number of Participants with Adverse Events (AEs)
研究概览
简要总结
The objective of this study is to assess the safety, tolerability, pharmacokinetics, and immunogenicity following multiple intravenous (IV) ascending doses of ABBV-8736 in healthy adult participants.
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
- Double (Participant, Care Provider)
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
- •Body mass index (BMI) is >= 18.0 to <= 32.0 kg/m^2 after rounding to the tenths decimal at Screening. BMI is calculated as weight in kg divided by the square of height measured in meters.
- •A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG.
排除标准
- •History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.
- •History of any clinically significant sensitivity or allergy to any medication or food.
- •Prior exposure to a TREM1 agent.
研究组 & 干预措施
Group 1: Dose A of ABBV-8736 Placebo
Participants will receive IV ABBV-8736 placebo dose A every 2 weeks for a total of 3 doses.
干预措施: Placebo (Drug)
Group 2: Dose B of ABBV-8736 Placebo
Participants will receive IV ABBV-8736 placebo dose B every 2 weeks for a total of 3 doses.
干预措施: Placebo (Drug)
Group 1: Dose A of ABBV-8736
Participants will receive intravenous (IV) ABBV-8736 dose A every 2 weeks for a total of 3 doses.
干预措施: ABBV-8736 (Drug)
Group 2: Dose B of ABBV-8736
Participants will receive IV ABBV-8736 dose B every 2 weeks for a total of 3 doses.
干预措施: ABBV-8736 (Drug)
结局指标
主要结局
Number of Participants with Adverse Events (AEs)
时间窗: Up to Approximately 113 Days
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 Concentration (Cmax) of ABBV-8736
时间窗: Up to Approximately 113 Days
Cmax of ABBV-8736.
Time to Cmax (Tmax) of ABBV-8736
时间窗: Up to Approximately 113 Days
Tmax of ABBV-8736.
Area under the plasma concentration-time curve from time 0 until the last measurable concentration (AUCtau) of ABBV-8736
时间窗: Up to Approximately 113 Days
AUCtau of ABBV-8736.
Observed plasma concentration at the end of a dosing interval (Ctrough) of ABBV-8736
时间窗: Up to Approximately 113 Days
Ctrough of ABBV-8736.
Apparent Terminal Phase Elimination Rate Constant (β) of ABBV-8736
时间窗: Up to Approximately 113 Days
β of ABBV-8736.
Terminal Phase Elimination Half-Life (t1/2) of ABBV-8736
时间窗: Up to Approximately 113 Days
t1/2 of ABBV-8736.
Clearance (CL) for Intravenous (IV) Dosing
时间窗: Up to Approximately 113 Days
CL for IV dosing.
Immunogenicity of ABBV-8736 as Determined by Anti-Drug Antibodies (ADAs)
时间窗: Up to Approximately 113 Days
Incidence and concentrations of ADAs. Neutralizing ADAs (NAb) may be evaluated.
次要结局
未报告次要终点