NCT04982991已完成1 期
A Phase 1, Open-label, 3-treatment Period, 1-sequence, Cross-over Study of the Pharmacokinetics, Safety and Tolerability After Single Ascending Oral Doses of SAR443820 in Healthy Adult Chinese and Japanese Female and Male Participants.
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Assessment of pharmacokinetic (PK) parameter: Cmax
研究概览
简要总结
Primary Objective:
To assess the pharmacokinetic parameters of SAR443820 after ascending single oral doses in healthy East Asian (Chinese and Japanese) adult participants.
Secondary Objective:
To assess the tolerability and safety of SAR443820 after ascending single oral doses in healthy East Asian (Chinese and Japanese) adult participants
详细描述
The duration of the study for a participant will be up to approximately 7 weeks and include:
- Screening period: up to 4 weeks (Day -28 to Day -2).
- Institutionalization period at each period of treatment: 4 days (Day -1 to Day 3, single SAR443820 administration on Day 1).
- Wash-out period: at least 5 days between each dosing.
- End-of-study visit: Period 3/ Day 6±1 day.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •East Asian (Chinese and Japanese) male and/or female participant must be 20 to 55 years of age inclusive, at the time of signing the informed consent.
- •Chinese or Japanese ethnicity, according to the following criteria:
- •Chinese; born in China or ethnic Chinese born outside of China, and a descendent of 4 ethnic Chinese grandparents who were all born in China.
- •Japanese; born in Japan or ethnic Japanese born outside of Japan, and a descendent of 4 ethnic Japanese grandparents who were all born in Japan.
- •Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and ECG.
- •Body weight within 50.0 and 100.0 kg, inclusive, if male, and between 40.0 and 90.0 kg, inclusive, if female, and body mass index (BMI) within the range 18.0 and 30.0 kg/m2, inclusive.
排除标准
- •Medical history of any seizure.
- •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, any live attenuated vaccine given within 3 months or any non-live vaccine given within 2 weeks before inclusion, and any biologics (antibody or its derivatives) given within 4 months before inclusion.
- •Positive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test.
- •Current psychiatric disorder, suicidal ideation in the previous 6 months (as assessed by the Columbia-Suicide Severity Rating Scale [C-SSRS]), or a lifetime suicide attempt. A "yes" response to questions 4 or 5 on the Suicidal Ideation section, or a score of 4 or 5 on the Intensity of Ideation section of the baseline/screening version of the C-SSRS at screening, or on the Since Last Visit version of the C-SSRS at baseline.
- •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
Experimental
Participants will receive a single sequence of 3 different doses of SAR443820 in a total of 3 treatment periods
干预措施: RIPK1 inhibitor (Drug)
结局指标
主要结局
Assessment of pharmacokinetic (PK) parameter: Cmax
时间窗: Up to day 3
Maximum plasma concentration
Assessment of pharmacokinetic (PK) parameter: AUC
时间窗: Up to day 3
Area under the plasma concentration versus time curve
Assessment of pharmacokinetic (PK) parameter: AUClast
时间窗: Up to day 3
Area under the plasma concentration versus time curve from time zero to the real time last
次要结局
- Assessment of adverse events (AEs)(Up to day 21)
研究者
研究点 (1)
Loading locations...
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