A Phase 1, Open Label, 3-treatment Period, 1-sequence, Cross-over Study to Evaluate Pharmacokinetics, Safety, and Tolerability After Single Ascending Oral Doses of SAR441566 in Healthy Adult Japanese Male Participants.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Assessment of plasma pharmacokinetic (PK) parameters for SAR441566: Cmax
研究概览
简要总结
This is a cross-over, Phase 1, 3-treatment period single sequence study. The purpose of this study is to characterize pharmacokinetics (PK), safety, and tolerability of single ascending oral doses of SAR441566 in healthy male Japanese participants, 18-55 years of age.
详细描述
The duration of the study for a participant will be up to approximately 65 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Japanese participants whose Japanese ethnicity is defined according to the following criteria: born in Japan or born outside of Japan, and are descendent of 4 ethnic Japanese grandparents who were all born in Japan.
- •Male participants between the ages of 18 and 55 years, inclusive
- •Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination including 12-lead ECG, and clinical laboratory tests)
- •Body weight between 50.0 and 100.0 kg, inclusive, and body mass index (BMI) between 18.0 and 30.0 kg/m^2, inclusive.
排除标准
- •Participants are excluded from the study if any of the following criteria apply:
- •Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, dermatological (including phototoxic dermatitis), osteomuscular, articular, psychiatric, systemic, ocular, immune disorders or infectious disease, or signs of acute illness.
- •Receipt of live (attenuated) vaccines within 3 months and/or non live vaccines (eg, COVID-19 vaccination) within 4 weeks prior to first dose on Day 1, or planned to receive these vaccines at any time throughout the study.
- •History of tuberculosis and/or a positive QuantiFERON-TB Gold (QFT) test.
- •Positive result on any of the following tests: hepatitis B surface (HBs Ag) antigen, anti-hepatitis B core antibody (anti-HBc Ab), anti-hepatitis C virus antibody (anti-HCV Ab), anti-human immunodeficiency virus 1 and 2 antibodies (anti-HIV1 and anti HIV2 Ab), SARS-CoV-2
- •Any medication within 14 days before inclusion (before first study treatment administration) or within 5 times the elimination half-life or pharmacodynamic half-life of the medication whichever the longest.
- •The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial
研究组 & 干预措施
SAR441566
Participants will receive single ascending doses of SAR441566 on day 1 of each 8-12-day cycle
干预措施: SAR441566 (Drug)
结局指标
主要结局
Assessment of plasma pharmacokinetic (PK) parameters for SAR441566: Cmax
时间窗: From Day 1 to Day 5 of each period (5 days per period)
Maximum plasma concentration observed
Assessment of plasma pharmacokinetic (PK) parameters for SAR441566: AUClast
时间窗: From Day 1 to Day 5 of each period (5 days per period)
Area under the plasma concentration versus time curve calculated using the trapezoidal method from time zero to the real time Tlast (AUClast)
Assessment of plasma pharmacokinetic (PK) parameters for SAR441566: AUC
时间窗: From Day 1 to Day 5 of each period (5 days per period)
Area under the plasma concentration versus time curve extrapolated to infinity (AUC)
次要结局
- Number of participants with adverse events (AE) and treatment-emergent adverse events (TEAEs)(Up to end of study visit (which will occur at latest day 37 of study))