Randomized, Double-blind, Single Subcutaneous Dose, Parallel Design Study of the Tolerability of Different SAR153191 Drug Products, That Differ With Respect to Manufacturing Processes and Formulation, at Different Concentrations and Doses, in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 53
- 主要终点
- Number of participants reporting injection site reactions
研究概览
简要总结
Primary objective:
To determine the tolerability of different SAR153191 drug products that differ with respect to manufacturing processes and formulation, at different concentrations and doses, after administration of single subcutaneous doses to healthy male subjects.
Secondary objectives:
To determine the pharmacokinetic profile of the different SAR153191 drug products administered subcutaneously.
To assess the safety of the different SAR153191 drug products administered subcutaneously.
详细描述
Up to 35 Days
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Having given written informed consent prior to any procedure related to the study.
排除标准
- •Participants are excluded from the study if any of the following criteria apply:
- •Any subject who, in the judgment of the Investigator, is likely to be noncompliant during the study, or unable to cooperate because of a language problem or poor mental development.
- •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
Group C
SAR153191 - P3 drug product concentration 2 dose 2
干预措施: SAR153191-P3 drug product (Drug)
Group A
SAR153191 - P3 drug product concentration 1 dose 1
干预措施: SAR153191-P3 drug product (Drug)
Group B
SAR153191 - P2 drug product concentration 2 dose 2
干预措施: SAR153191-P2 drug product (Drug)
Group D
SAR153191 - P3 drug product concentration 3 dose 3
干预措施: SAR153191-P3 drug product (Drug)
Group B'
SAR153191 - P2 drug product concentration 2 dose 3
干预措施: SAR153191-P2 drug product (Drug)
Group C'
SAR153191 - P3 drug product concentration 2 dose 3
干预措施: SAR153191-P3 drug product (Drug)
Group E'
SAR153191 - CIF3 drug product concentration 2 dose 3
干预措施: SAR153191-C1F3 drug product (Drug)
结局指标
主要结局
Number of participants reporting injection site reactions
时间窗: At predose and on Days 1, 2, 3, 4, 5, 7, 9, 11, 14, 21, and 35 following SAR153191 administration
Injection site reactions include pain, erythema an edema.
次要结局
- Pharmacokinetics: Cmax(At predose and on Days 1, 2, 3, 4, 5, 7, 9, 11, 14, 21 and 35 following SAR153191 administration)
- Pharmacokinetics: t1/2z(At predose and on Days 1, 2, 3, 4, 5, 7, 9, 11, 14, 21 and 35 following SAR153191 administration)
- Pharmacokinetics: AUClast(At predose and on Days 1, 2, 3, 4, 5, 7, 9, 11, 14, 21 and 35 following SAR153191 administration)
- Incidence of anti-SAR153191 antibodies(At Day 1 predose and on Days 7, 21, and 35 (plus follow-up if positive))
- Pharmacokinetics: tmax(At predose and on Days 1, 2, 3, 4, 5, 7, 9, 11, 14, 21 and 35 following SAR153191 administration)
- Pharmacokinetics: AUC(At predose and on Days 1, 2, 3, 4, 5, 7, 9, 11, 14, 21 and 35 following SAR153191 administration)
- Safety: Number of participants who experienced Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs) and/or Treatment-Emergent Adverse Events of Special Interest (AESI)(Up to 35 Days)