A Randomized, Double-blind, Glucagon and Placebo-controlled Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of Single Escalating Doses of SAR438544 Administered by Subcutaneous Route in Healthy Subjects and Patients With Type 1diabetes Mellitus
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Number of patients with adverse events
研究概览
简要总结
Primary Objective:
To assess the tolerability and safety of SAR438544 after single ascending subcutaneous (SC) doses in healthy subjects and in type 1 diabetes mellitus (T1DM) patients.
Secondary Objective:
To assess the preliminary pharmacodynamics (PD) and pharmacokinetic (PK) parameters of SAR438544 after single ascending SC doses in healthy subjects and in T1DM patients.
详细描述
Healthy subjects:
The total duration of study per subject is up to 4.5 weeks with 2 to 21 days screening period, 1 day for treatment, and 7 days (+/- 1 day) follow-up after IMP administration.
T1DM patients:
The total duration of study per patient is up to 5.5 weeks with 3 to 28 days screening period, 1 day for treatment, and 7 days (+/- 1 day) follow-up after IMP administration.
One or more interim analyses may be performed to support decisions for the next steps of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
SAR438544 dose 1
Single dose of SAR438544 given SC under fasting conditions
干预措施: SAR438544 (Drug)
SAR438544 dose 2
Single dose of SAR438544 given SC under fasting conditions
干预措施: SAR438544 (Drug)
SAR438544 dose 3
Single dose of SAR438544 given SC under fasting conditions
干预措施: SAR438544 (Drug)
Placebo
Single dose of placebo given SC under fasting conditions
干预措施: placebo (Drug)
Glucagon
Single dose of glucagon given SC under fasting conditions
干预措施: r-glucagon (Drug)
SAR438544 Optional Dose
Optional lower, intermediate, or higher dose of SAR438544 given SC under fasting conditions
干预措施: SAR438544 (Drug)
结局指标
主要结局
Number of patients with adverse events
时间窗: Day 1 to Day 7 (+/- 1 day)
次要结局
- Assessment of PK parameter (recombinant glucagon and SAR438544): terminal half life(Day 1)
- Assessment of PK parameter (recombinant glucagon and SAR438544): AUC(Day 1)
- Assessment of PK parameter (recombinant glucagon and SAR438544): partial AUCs (AUC0-t)(Day 1)
- Assessment of PD parameter: continuous monitoring of blood glucose levels over a period of 6 hours post-dose(Day 1)
- Assessment of PD parameter: area under plasma concentration of the BG-time curve between investigational medicinal product (IMP) dosing and time t (BG-AUC0-t)(Day 1)
- Assessment of PD parameter: BG-maximum concentration (BG-Cmax)(Day 1)
- Assessment of PD parameter: BG-time to Cmax (BG-tmax)(Day 1)
- Assessment of PK parameter (recombinant glucagon and SAR438544): Cmax(Day 1)
- Assessment of PK parameter (recombinant glucagon and SAR438544): tmax(Day 1)
- Assessment of PK parameter (recombinant glucagon and SAR438544): tlast(Day 1)
- Assessment of PK parameter (recombinant glucagon and SAR438544): area under curve from zero time until the last measurable concentration (AUClast)(Day 1)