A Randomized, Double-blind, Placebo-controlled Study of the Safety, Tolerability and Pharmacokinetics of Ascending Single and 14-day Repeated Oral Doses of SAR443820 in Healthy Adult Participants.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Parts 1a and 1b: Number of participants with adverse events
研究概览
简要总结
This is a Phase 1, single-center study conducted in 2 parts:
Part 1a, single ascending dose (SAD-TDU16519): Double-blind, randomized, placebo-controlled sequential ascending single oral doses including up to 6 cohorts. Each cohort will include 8 participants (6 receiving SAR443820 and 2 placebo).
Part 1b (TDU16519): - Open label, single SAR443820 dose in one or two separated cohort(s) for SAR443820 measurements in CSF and in plasma.
Part 2, multiple ascending dose (MAD -TDR16520): Double-blind, randomized, placebo-controlled, sequential ascending repeated oral doses for 14 days, including up to 4 cohorts. Each cohort will include 10 participants (8 receiving SAR443820 and 2 placebo).
详细描述
The duration of the study for a participant will include:
Screening Period: up to 28 days
Part 1a:
Treatment in fasted condition: 1 day (Day 1). Study observation Period from Day -2/Day -1 to Day 3. Follow-up with the end of study: from Day 5 to Day 7. Total duration from screening per participant: up to 5 weeks.
Part 1b:
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
- •Male and/or female participant, between 18 and 55 years of age, inclusive. Body weight between 50.0 and 100.0 kg, inclusive, if male, and between 40.0 and 90.0 kg, inclusive, if female, body mass index between 18.0 and 30.0 kg/m2, inclusive.
- •Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination).
- •Having given written informed consent prior to undertaking any study-related procedure.
- •Not under any administrative or legal supervision or under institutionalization due to regulatory or juridical order.
排除标准
- •Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteo-muscular, articular, psychiatric, systemic, ocular, gynecologic (if female), or infectious disease, or signs of acute illness.
- •Personal medical history of seizure.
- •Frequent headaches and/or migraine, recurrent nausea and/or vomiting (for vomiting only: more than twice a month).
- •Any medication (including St John's Wort) within 14 days before inclusion or within 5 times the elimination half-life or pharmacodynamic half-life of the medication, with the exception of hormonal contraception or menopausal hormone replacement therapy; any vaccination within the last 28 days and any biologics (antibody or its derivatives) given within 4 months before inclusion.
- •Positive result for hepatitis B, C or HIV
- •Positive result on urine drug screen
- •Positive alcohol test.
- •Any consumption of citrus fruits or their juices within 5 days before inclusion.
- •Current psychiatric disorder, suicidal ideation in the previous 6 months (as assessed by the C-SSRS), or a lifetime suicide attempt.
- •Additional exclusion criteria applied, and specially for Part 1b, criteria related to the study procedure of lumbar puncture.
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
SAR443820
Single dose oral ascending dose (parts 1a and 1b) and multiple ascending oral dose (part 2) of SAR443820
干预措施: SAR443820 (Drug)
Placebo
Single dose oral ascending dose (part 1a) and multiple ascending oral dose (part 2) of matching placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Parts 1a and 1b: Number of participants with adverse events
时间窗: Day1 up to Day 7 (end of study visit)
Part 2: Number of participants with adverse events
时间窗: Day1 up to Day 21 (end of study visit)
次要结局
- Parts 1a and 1b: Assessment of pharmacokinetic parameter of SAR443820: Cmax in plasma(Day1)
- Parts 1a and 1b: Assessment of pharmacokinetic parameter of SAR443820: tmax in plasma(Day 1)
- Parts 1a and 1b : Assessment of pharmacokinetic parameter of SAR443820: AUC in plasma(Day1)
- Parts 1a and 1b : Assessment of pharmacokinetic parameter of SAR443820: t1/2z in plasma(Day1)
- Part1b: SAR443820 concentrations in cerebrospinal fluid (CSF) samples(Day1)
- Part 2: Assessment of pharmacokinetic parameter of SAR443820: Cmax in plasma(Day1 and Day14)
- Part 2: Assessment of pharmacokinetic parameter of SAR443820: tmax in plasma(Day1 and Day14)
- Part 2: Assessment of pharmacokinetic parameter of SAR443820: AUC tau in plasma(Day1 and Day14)
- Part 2 Assessment of pharmacokinetic parameter of SAR443820: t1/2z in plasma(Day14)
- Part 2: Day14/Day1 of 4β-hydroxycholesterol ratio in plasma(Day1 and Day14)