A Randomized, Participant- and Investigator-blinded, Placebo-controlled, Single Ascending Dose and Multiple Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of INE963 in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Number of Subjects with Significant Clinical Safety Labs, reporting SAEs and AEs and ECG findings
研究概览
简要总结
The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of single ascending doses and multiple doses of INE963 given orally in healthy participants.
详细描述
This is a randomized, participant- and investigator-blinded, placebo-controlled, single ascending and multiple oral dose study in healthy participants. The study consisted of two parts:
- Part A was a single ascending dose (SAD) study with 6 planned cohorts: (A1, A2, A4, A5, A6 and A7) of 8 participants each and 1 cohort (A3) with 10 participants, as randomization ratio 4:1 was originally planned due to the food effect cohort. There was also an optional cohort of 8 subjects (A8).
- Part B was a multiple dose (MAD) study with 2 planned cohort of 9 participants (B1 and B2; randomization ratio 2:1). There was also an optional cohort of 9 subjects (B3).
Cohort B2 and Optional Cohorts A8 and B3 were not dosed since the study was terminated early as per joint decision between the Principal Investigator and the Sponsor. Importantly, the decision to terminate the study early was not taken as a consequence of any safety concerns seen with INE963 administration in healthy volunteers.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
INE963
Part A is a single ascending dose (SAD) study with 7 planned cohorts Part B is a multiple dose (MD) study with 2 planned cohort q24h x 3 day of either INE963 or placebo
干预措施: INE 963 (Drug)
Placebo group
Part A is a single ascending dose (SAD) study with 7 planned cohorts Part B is a multiple dose (MD) study with 2 planned cohort q24h x 3 day of either INE963 or placebo
干预措施: Placebo (Other)
结局指标
主要结局
Number of Subjects with Significant Clinical Safety Labs, reporting SAEs and AEs and ECG findings
时间窗: Dose escalation (21 days)
Number of Subjects with Significant Clinical Safety Labs, reporting SAEs and AEs and ECG findings, as judged by investigator at each dose escalation review meetings
次要结局
- INE963 pharmacokinetic parameters T1/2 in SAD Part(Day 1, 2, 3, 4, 6, 8, 9, 12 and 16)
- INE963 pharmacokinetic parameters in MAD Part (Cmax)(Day 1, 2, 3, 4, 6, 8, 10, 11, 14 and Day 18)
- Baseline AAG concentration(Baseline)
- INE963 pharmacokinetic parameters AUC in SAD Part(Day 1, 2, 3, 4, 6, 8, 9, 12 and 16)
- INE963 pharmacokinetic parameters in MAD Part (T1/2)(Day 1, 2, 3, 4, 6, 8, 10, 11, 14 and Day 18)
- INE963 pharmacokinetic parameters Tmax in SAD Part(Day 1, 2, 3, 4, 6, 8, 9, 12 and 16)
- INE963 pharmacokinetic parameters Cmax in SAD Part(Day 1, 2, 3, 4, 6, 8, 9, 12 and 16)
- INE963 pharmacokinetic parameters Vz/F in SAD Part(Day 1, 2, 3, 4, 6, 8, 9, 12 and 16)
- INE963 pharmacokinetic parameters in MAD Part (AUC)(Day 1, 2, 3, 4, 6, 8, 10, 11, 14 and Day 18)
- INE963 pharmacokinetic parameters in MAD Part (Tmax)(Day 1, 2, 3, 4, 6, 8, 10, 11, 14 and Day 18)
- INE963 pharmacokinetic parameters in MAD Part (Vz/F)(Day 1, 2, 3, 4, 6, 8, 10, 11, 14 and Day 18)