A Blinded, Randomized, Placebo-controlled, Multiple Dose Study to Determine the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ESK-001 Tablets Administered Over 14days to Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Alumis Inc
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Incidence of Adverse Events (AEs)
研究概览
简要总结
Multiple Dose Study to Determine the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ESK-001 in Healthy Participants
详细描述
This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.)
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participant is a man or woman between the ages of 18 and 60years, inclusive, at the Screening Visit
- •Participant is healthy as determined by medical history, physical examination, vital signs, and routine laboratory parameters
- •Other inclusions as specified in the protocol
排除标准
- •Participant has a prior exposure to ESK-001
- •Participant has a history of hypersensitivity to any of the ingredients of ESK-001
- •Other exclusions as specified in the protocol
研究组 & 干预措施
Placebo
Placebo for ESK-001
干预措施: Placebo (Other)
结局指标
主要结局
Incidence of Adverse Events (AEs)
时间窗: Up to 14 days
Safety and tolerability
Incidence of Serious Adverse Events (SAEs)
时间窗: Up to 14 days
Safety and tolerability
次要结局
- The area under plasma concentration-time curve from time zero extrapolated to last measurable concentration (AUCt) for ESK001 on Day 1 and Day 14(Up to 14 days)
- The area under the plasma concentration-curve over the dosing interval (AUC(0-τ)) for ESK001 on Day1 and Day 14(Up to 14 days)
- The observed maximum plasma concentration (Cmax) for ESK001 on Day 1 and Day 14.(Up to 14 days)
- The time to reach the observed maximum plasma concentration (tmax) for ESK001 on Day 1 and Day 14.(Up to 14 days)
- Apparent plasma elimination half-life (t½λz) for ESK001 on Day 1 and Day 14(Up to 14 days)
- Apparent clearance CL(Clearance)/F for ESK001 on Day 1(Up to 14 days)
- The accumulation ratio for AUC(0-τ) (RAC AUC(0-τ)) for ESK001 on Day 14(Up to 14 days)
- The accumulation ratio for Cmax (RAC Cmax) for ESK001 on Day 14.(Up to 14 days)
- Cytokine induction of pSTAT expression and downstream cytokine production as a measure of tyk2 pathway inhibition by ESK001(14 days after first dose)