A First-in-Human Single Ascending Dose, Mass Balance, and Food Effect Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ABBV-1088 in Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Time to Cmax (Tmax) of ABBV-1088
研究概览
简要总结
This study will assess the single dose safety, tolerability and pharmacokinetic properties of ABBV-1088 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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI is ≥ 18.0 to ≤ 32.0 kg/m^2 after rounding to the tenths decimal at screening.
- •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 cardiac disease, including congenital structural/conduction abnormalities, cardiomyopathy, myocardial infarction, cardiac arrhythmia.
- •History of or active medical condition(s) or surgical procedure(s) that might affect gastrointestinal motility, pH, or absorption [e.g., Crohn's disease, chronic GERD, celiac disease, gastroparesis, short bowel syndrome, gastric surgery (except pyloromyotomy for pyloric stenosis during infancy), cholecystectomy, vagotomy, bowel resection, etc.].
- •History of suicidal ideation within one year prior to study drug administration as evidenced by answering "yes" to questions 4 or 5 on the suicidal ideation portion of the C-SSRS completed at Screening, or any history of suicide attempts within the last two years.
- •History of any clinically significant neurological, respiratory (except mild asthma as a child), endocrine, metabolic, renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.
研究组 & 干预措施
Group 1- ABBV-1088 Dose A
Participants will receive single dose of ABBV-1088 dose A on day 1
干预措施: Drug: ABBV-1088 (Drug)
Group 1- Placebo
Participants will receive single dose of placebo day 1
干预措施: Drug: Placebo for ABBV-1088 (Drug)
Group 2- ABBV-1088 Dose B
Participants will receive single dose of ABBV-1088 dose B on day 1
干预措施: Drug: ABBV-1088 (Drug)
Group 2- Placebo
Participants will receive single dose of placebo day 1
干预措施: Drug: Placebo for ABBV-1088 (Drug)
Group 3- ABBV-1088 Dose C
Participants will receive single dose of ABBV-1088 dose C on day 1
干预措施: Drug: ABBV-1088 (Drug)
Group 3- Placebo
Participants will receive single dose of placebo day 1
干预措施: Drug: Placebo for ABBV-1088 (Drug)
Group 4- ABBV-1088 Dose D
Participants will receive single dose of ABBV-1088 dose D on day 1
干预措施: Drug: ABBV-1088 (Drug)
Group 4- Placebo
Participants will receive single dose of placebo day 1
干预措施: Drug: Placebo for ABBV-1088 (Drug)
Group 5- ABBV-1088 Dose E
Participants will receive single dose of ABBV-1088 dose E on day 1
干预措施: Drug: ABBV-1088 (Drug)
Group 5- Placebo
Participants will receive single dose of placebo day 1
干预措施: Drug: Placebo for ABBV-1088 (Drug)
Group 6- ABBV-1088 Dose F
Participants will receive single dose of ABBV-1088 dose F on day 1
干预措施: Drug: ABBV-1088 (Drug)
Group 6- Placebo
Participants will receive single dose of placebo day 1
干预措施: Drug: Placebo for ABBV-1088 (Drug)
结局指标
主要结局
Time to Cmax (Tmax) of ABBV-1088
时间窗: Up to approximately 11 days
Tmax of ABBV-1088
Maximum Plasma Concentration (Cmax) of ABBV-1088
时间窗: Up to approximately 11 days
Cmax of ABBV-1088
Area Under the Concentration-Time Curve From Time 0 to Time t (AUCt) of ABBV-1088
时间窗: Up to approximately 11 days
AUCt of ABBV-1088
Terminal Phase Elimination Half-Life (t1/2) of ABBV-1088
时间窗: Up to approximately 11 days
Terminal phase elimination half-life of ABBV-1088
Terminal Phase Elimination Rate Constant (Beta) of ABBV-1088
时间窗: Up to approximately 11 days
Terminal phase elimination rate constant (beta) of ABBV-1088
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of ABBV-1088
时间窗: Up to approximately 11 days
AUCinf of ABBV-1088
Number of Participants With Adverse Events (AEs)
时间窗: Up to Day 32
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
次要结局
未报告次要终点