NCT05099822终止1 期
A Phase 1, Randomized, Double-blind, Placebo-controlled, Single-center, First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Ascending Doses of CC-97489 in Healthy Adult Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Celgene
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Incidence of Adverse Events (AEs)
研究概览
简要总结
This study aims to evaluate the safety, tolerability, of CC-97489
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 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
- •In good health, as determined by the investigator based on past medical history, physical examination, vital signs and clinical laboratory safety tests at screening.
- •Body mass index (BMI) ≥ 18 and ≤ 33 kg/m^2, inclusive. BMI = weight (kg)/(height [m])^2
排除标准
- •Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, echocardiogram (ECG), or clinical laboratory determinations beyond what is consistent with healthy participants
- •Other protocol-defined inclusion/exclusion criteria apply
研究组 & 干预措施
Administration of CC-97489
Experimental
干预措施: CC-97489 (Drug)
Administration of Placebo
Experimental
干预措施: Placebo (Other)
结局指标
主要结局
Incidence of Adverse Events (AEs)
时间窗: 28 days after the last dose
Incidence of Serious Adverse Events (SAEs)
时间窗: 28 days after the last dose
Number of participants with clinically significant changes in electrocardiogram parameters
时间窗: Day 21
Incidence of clinically significant changes in vital signs: Body temperature
时间窗: Day 21
Incidence of clinically significant changes in vital signs: Respiratory rate
时间窗: Day 21
Incidence of clinically significant changes in vital signs: Blood pressure
时间窗: Day 21
Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
时间窗: Day 18
Incidence of clinically significant changes in vital signs: Heart rate
时间窗: Day 21
Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
时间窗: Day 18
Incidence of clinically significant changes in clinical laboratory results: Hematology tests
时间窗: Day 18
次要结局
- Pharmacokinetics - Minimum plasma drug concentration (Cmin)(Up to 96 hours after the last dose of study drug)
- Pharmacokinetics - Area under the plasma concentration (AUC)-time curve from time zero extrapolated to infinity (AUC0-∞)(Up to 96 hours after the last dose of study drug)
- Pharmacokinetics - Area under the plasma concentration-time curve from time zero to tau (τ) where τ is the dosing interval (AUC0- 0-τ)(Up to 96 hours after the last dose of study drug)
- Pharmacokinetics - Apparent total volume of distribution when dosed orally (Vz/F)(Up to 96 hours after the last dose of study drug)
- Pharmacokinetics - Apparent total plasma clearance when dosed orally (CL/F)(Up to 96 hours after the last dose of study drug)
- Pharmacokinetics - Area under the plasma concentration-time curve from time zero to time t, where t is the time point of the last measurable concentration (AUC0-t)(Up to 96 hours after the last dose of study drug)
- Pharmacokinetics - Area under the plasma concentration-time curve from time zero to 24 hours postdose (AUC0-24)(Up to 96 hours after the last dose of study drug)
- Pharmacokinetics - Ratio of accumulation based on Day 1 and Day 14 AUC0- 0-τ and Cmax, as appropriate (Rac)(Up to 96 hours after the last dose of study drug)
- Pharmacodynamics - Measurement of : plasma and whole-blood anandamide (AEA) levels(Up to 168 hours after the last dose of study drug)
- Pharmacodynamics - Measurement of plasma and whole-blood 2-arachidonoylglycerol (2-AG) levels(Up to 168 hours after the last dose of study drug)
- Pharmacokinetics - Time to maximum observed plasma concentration (Tmax)(Up to 96 hours after the last dose of study drug)
- Pharmacokinetics - Terminal elimination half-life in plasma (t½,z)(Up to 96 hours after the last dose of study drug)
- Pharmacodynamics - Evaluation of monoacylglycerol lipase (MGLL) enzymatic inhibition by CC-97489 in peripheral blood mononuclear cells (PBMCs)(Up to 168 hours after the last dose of study drug)
- Pharmacodynamics: Peripheral blood mononuclear cell (PBMC) fatty acid amide hydrolase (FAAH) inhibition(Up to 168 hours after the last dose of study drug)
- Pharmacokinetics - Maximum observed plasma concentration (Cmax)(Up to 96 hours after the last dose of study drug)
研究者
研究点 (1)
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