A Single and Multiple Dose-escalation First-in-human With Food-effect Study Evaluating the Safety, Tolerability and Pharmacokinetics of SRT-015 Administered Orally.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- 3. To evaluate maximum serum concentration of SRT-015 following single and multiple oral dose administration in healthy subjects (Cmax)
研究概览
简要总结
This is phase 1 first-in-human trial evaluating SRT-015 to assess safety, tolerability and pharmacokinetics. This study will be conducted in 3 parts - SAD, MAD and Food Effect with target of 96 healthy volunteers.
This will be a single center, Phase 1, randomized, double-blind, placebo controlled, SAD and MAD study of dose escalation cohorts evaluating administration of SRT-015 or placebo. Additionally, PK will be assessed in fed and fasting states.
详细描述
The study will be divided into three parts:
Part A: SAD- Randomized, double-blind, placebo-controlled single oral escalating dose of SRT-015 or placebo in five cohorts (A1-A5). Each cohort will include 8 healthy subjects (6 randomized to receive SRT-015 and 2 to receive placebo). Two subjects from each cohort (1 to receive SRT-015 and 1 to receive placebo) will be dosed as sentinels, with the remainder of the subjects of each cohort (5 to receive SRT-015 and 1 to receive placebo) dosed at least the following day.
An extension cohort (Cohort A6) will allow investigation of a repeat or intermediate dose, at the discretion of the Sponsor or Safety Review Committee (SRC).
Part B: MAD- Randomized, double-blind, placebo-controlled multiple oral escalating dose of SRT-015 or placebo in four cohorts (B1-B4). Each cohort will include 8 healthy subjects (6 randomized to receive SRT-015 and 2 to receive placebo). Subjects will be treated with SRT-015 or placebo for 7 days.
An extension cohort (Cohort B5) will allow investigation of a repeat or intermediate dose at the discretion of Sponsor and SRC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males or females aged 18 to 45 years of age with a BMI >18.0 and <32.0 kg/m2 and body weight greater than or equal to 50kg for males and greater than or equal to 45 kg for females.
- •Casual smoker (defined by the consumption of no more than 5 cigarettes per week, and willing to abstain from the consumption of cigarettes and related products for the study duration) or non smoker.
- •Agree to use appropriate contraception.
排除标准
- •Any clinically significant abnormality at physical examination, clinically significant abnormal laboratory test results (liver function tests must be strictly within normal ranges) or positive test for HIV, hepatitis B, or hepatitis C found during medical screening.
- •Positive urine drug screen or alcohol breath test at screening and check-in (Day -1).
- •Positive pregnancy test, or breast feeding.
- •Clinically significant 12-lead ECG abnormalities.
- •Any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study.
研究组 & 干预措施
Drug :SRT-015
Experimental, Single and Multiple Oral escalating dose and Food Effect Cohort
干预措施: SRT-015 (Drug)
Matching Placebo for SRT-015
干预措施: Matching Placebo for SRT-015 (Other)
结局指标
主要结局
3. To evaluate maximum serum concentration of SRT-015 following single and multiple oral dose administration in healthy subjects (Cmax)
时间窗: Up to two weeks
Maximum serum concentration (mg/L)
To evaluate the safety and tolerability following of single and multiple oral doses of SRT-015 in healthy subjects
时间窗: Up to two weeks
Number of participants with serious and other non-serious adverse events
To evaluate the exposure to SRT-015 following single and multiple oral dose administration in healthy subjects (AUC last)
时间窗: Up to two weeks
Area under the serum concentration-time curve from time zero to last measurable concentration (mg\*h/L)
次要结局
- To compare the exposure to SRT-015 (AUClast) in capsule formulation vs suspension formulation and fed vs fasted state(Up to two weeks)
- To compare maximum serum concentration of SRT-015 (Cmax) in capsule formulation vs suspension formulation and fed v fasted state(Up to two weeks)