A Pilot Clinical Trial Investigating the Intra-subject Variability of Pharmacokinetics and Glucodynamics of BioChaperone Insulin Lispro U-100 Product (2 Single Doses of 0.2 U/kg) and U-200 Product (2 Single Doses of 0.2 U/kg) in Healthy Male and Female
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Adocia
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Cmax Lisp
研究概览
简要总结
This is a double-blinded, randomised, single-centre phase I pilot trial for exploring the feasibility of a pivotal clinical trial establishing bioequivalence between BioChaperone insulin lispro U-200 and BioChaperone insulin lispro U-100 in healthy subjects.
Each subject will be randomly allocated to a sequence of four treatments, i.e. two single doses of BioChaperone insulin lispro U-200 of 0.2 U·kg BW-1 and two single doses of BioChaperone insulin lispro U-100 of 0.2 U·kg BW-1 on four separate dosing visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female subjects, considered generally healthy upon completion of medical history, physical examination and biochemical investigations as judged by the Investigator.
- •Age ≥ 18 and ≤ 64 years, both inclusive.
- •Body Mass Index (BMI) between 18.5 and 28.0 kg∙m-2, both inclusive.
- •Fasting Plasma Glucose (FPG) ≤ 5.6 mmol/L (100 mg/dL).
- •Signed and dated informed consent obtained before any trial-related activities, i.e. any procedures that would not have been performed during normal management of the subject).
排除标准
- •Known or suspected hypersensitivity to trial product(s) or related products.
- •Receipt of any investigational medicinal product within 3 months before randomisation in this trial.
研究组 & 干预措施
BioChaperone Lispro U-100
injection of 2 doses of 0.2 U/kg on separate visits
干预措施: BioChaperone Lispro U-100 (Drug)
BioChaperone Lispro U-200
injection of 2 doses of 0.2 U/kg on separate visits
干预措施: BioChaperone Lispro U-200 (Drug)
结局指标
主要结局
Cmax Lisp
时间窗: 8 hours
Maximum observed insulin lispro serum concentration
AUCLisp (0-inf)
时间窗: 8 hours
Area under the insulin lispro serum concentration - time curve from t=0 to infinity
次要结局
- tmax Lisp(8 hours)
- AUCGIR(0-8h)(8 hours)
- Number of Adverse events(Up to 9 weeks)
- Local tolerability(Up to 9 weeks)
- GIRmax(8 hours)
- tGIRmax(8 hours)