jRCT2071220112已完成不适用
A Phase 1, open-label, randomized, parallel study to evaluate the pharmacokinetics, safety, and tolerability of single-dose SAR443765 in healthy adult Japanese participants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Sanofi K.K.
- 入组人数
- 12
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Other
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 45age old under（—）
- 性别
- All
入选标准
- •Participants are eligible to be included in the study only if all of the following criteria apply:
- •Japanese male or female participant, must be 18 to 45 years of age inclusive, at the time of signing the informed consent.
- •Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination).
- •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/m^2 (inclusive).
- •Contraceptive used by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. A female participant is eligible to participate if she is not pregnant or breastfeeding.
- •Capable of giving signed informed consent with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
排除标准
- •Participants are excluded from the study if any of the following criteria apply:
- •Medical conditions
- •Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, gynecologic (if female), or infectious disease, or signs of acute illness, unless the investigator considers an abnormality to be not clinically significant.
- •Subject has clinical signs and symptoms consistent with COVID-19, eg, fever, dry cough, dyspnea, loss of taste and smell, sore throat, fatigue or confirmed infection by appropriate laboratory test within the last 4 weeks prior to IMP administration. Subject who had severe course of COVID-19 (ie, hospitalization, extracorporeal membrane oxygenation [ECMO], mechanically ventilated).
- •Frequent headaches and/or migraine, recurrent nausea and/or vomiting (for vomiting only: more than twice a month).
- •Blood donation of 400 mL within 12 weeks (male) or 16 weeks (female), 200 mL within 4 weeks or apheresis donation within 2 weeks before the first IMP administration.
- •Symptomatic postural hypotension, irrespective of the decrease in blood pressure, or asymptomatic postural hypotension defined as a decrease in systolic blood pressure >=30 mmHg within 3 minutes when changing from supine to standing position.
- •Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician. Participants with a history of mild seasonal allergies might be included at Investigator's discretion.
- •Other exclusions
- •Participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures.
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
结局指标
主要结局
-
Serum PK parameters at least Cmax, AUClast, and AUC
次要结局
- Local tolerability at injection site
- Assessment of adverse events (AEs) /treatment-emergent adverse events (TEAEs)
- Anti-drug antibodies (ADA)
研究者
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