A Randomized, Double-blind, Placebo-controlled, Phase 1a Study to Evaluate the Safety and Pharmacokinetics of Single Ascending Doses of ABBV-141 in Healthy Adult Western and Asian Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- AUC of ABBV-141 from Time 0 to Infinity (AUCinf)
研究概览
简要总结
The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and immunogenicity after single ascending doses (SAD) of ABBV-141 in healthy adult Western and Asian participants.
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
- Double (Participant, Investigator)
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
- •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).
- •Body Mass Index (BMI) is ≥ 18.0 to ≤ 32.0 kg/m2 after rounding to the tenths decimal.
- •For Part 2 only:
- •Han Chinese ethnicity or Japanese ethnicity based on the following criteria:
- •Han Chinese: First-generation Han Chinese with both parents of Han Chinese descent.
- •Japanese: First- or second-generation Japanese with both parents and all four grandparents born in Japan and of Japanese descent.
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, topical creams, or food.
- •Additionally for Part 1, only:
- •Presence of foreign bodies, local irritation or infections, active skin diseases, tattoos, and/or scars on the thighs which may preclude the skin biopsy collection site planned as per schedule of activities.
- •History of bruising easily, bleeding disorders, thrombocytopenia, or hypo-coagulation disorder.
- •History of sensitivity to or allergies to adhesives or evidence of fragile or easily damaged skin.
- •Evidence of hypertrophic scarring.
研究组 & 干预措施
Part 1, ABBV-141 (Intravenous [IV])
Western participants will receive a single IV dose of ABBV-141.
干预措施: ABBV-141 (Drug)
Part 1, Placebo for ABBV-141 (IV)
Western participants will receive a single IV dose of placebo for ABBV-141.
干预措施: Placebo for ABBV-141 (Drug)
Part 1, ABBV-141 (subcutaneous [SC])
Western participants will receive a single SC dose of ABBV-141.
干预措施: ABBV-141 (Drug)
Part 1, Placebo for ABBV-141 (SC)
Western participants will receive a single SC dose of placebo for ABBV-141.
干预措施: Placebo for ABBV-141 (Drug)
Part 2, ABBV-141 (IV)
Asian participants will receive a single IV dose of ABBV-141.
干预措施: ABBV-141 (Drug)
Part 2, Placebo for ABBV-141 (IV)
Asian participants will receive a single IV dose of placebo for ABBV-141.
干预措施: Placebo for ABBV-141 (Drug)
Part 2, ABBV-141 (SC)
Asian participants will receive a single SC dose of ABBV-141.
干预措施: ABBV-141 (Drug)
Part 2, Placebo for ABBV-141 (SC)
Asian participants will receive a single SC dose of placebo for ABBV-141.
干预措施: Placebo for ABBV-141 (Drug)
结局指标
主要结局
AUC of ABBV-141 from Time 0 to Infinity (AUCinf)
时间窗: Up to Day 85
AUCinf of ABBV-141 will be assessed.
Terminal Phase Elimination Rate Constant (β) of ABBV-141
时间窗: Up to Day 85
Terminal phase elimination rate constant (β) of ABBV-141 will be assessed.
Terminal Phase Elimination Half-life (t1/2) of ABBV-141
时间窗: Up to Day 85
Terminal phase elimination half-life (t1/2) of ABBV-141 will be assessed.
Dose Normalized Cmax of ABBV-141
时间窗: Up to Day 85
Dose normalized Cmax of ABBV-141 will be assessed.
Dose Normalized AUC of ABBV-141
时间窗: Up to Day 85
Dose normalized AUC of ABBV-141 will be assessed.
Number of Adverse Events (AEs)
时间窗: Baseline to Day 85
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.
Maximum Observed Plasma Concentration (Cmax) of ABBV-141
时间窗: Up to Day 85
Cmax of ABBV-141 will be assessed.
Time to Cmax (Tmax) of ABBV-141
时间窗: Up to Day 85
Tmax of ABBV-141 will be assessed.
Area Under the Serum Concentration-time Curve (AUC) of ABBV-141 from time 0 to the time of last measurable concentration (AUCt)
时间窗: Up to Day 85
AUCt of ABBV-141 will be determined.
次要结局
未报告次要终点