A Double-blind, Comparator-controlled, Randomised, Three-period Crossover Euglycemic Clamp Trial to Evaluate Pharmacokinetics of Single Doses of BioChaperone Insulin Lispro in Healthy Japanese Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Adocia
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- AUCLispro(0-30min)
研究概览
简要总结
This is a double-blind, randomised, three period crossover phase 1 trial using automated 8-hour euglycemic clamps in healthy Japanese subjects.
Each subject will be randomly allocated to one out of nine sequences to receive either three single doses of BioChaperone insulin lispro or one single dose of Humalog® and two single doses of BioChaperone insulin lispro on three separate dosing visits.
The total trial maximum duration for a subject will be up to 10 weeks.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Japanese male or female subjects by completion of medical history, physical examination and biochemical investigations as judged by the Investigator.
- •BMI between 18.5 and 25.0 kg∙m-2, both inclusive.
- •Fasting Plasma Glucose ≤ 5.6 mmol/L (100 mg/dL).
- •Signed and dated informed consent obtained before any trial-related activities.
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.
- •Any history or presence of a life threatening disease (i.e. cancer except basal cell skin cancer or squamous cell skin cancer), or of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic (including type 1 and type 2 diabetes mellitus, haematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, gynaecologic (if female), or infectious disease, or signs of acute illness as judged by the investigator.
- •History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction.
研究组 & 干预措施
BioChaperone insulin lispro 0.1 U/kg
干预措施: Biochaperone insulin lispro 0.1 U/kg (Drug)
BioChaperone insulin lispro 0.2 U/kg
干预措施: Biochaperone insulin lispro 0.2 U/kg (Drug)
BioChaperone insulin lispro 0.4 U/kg
干预措施: Biochaperone insulin lispro 0.4 U/kg (Drug)
Humalog®
干预措施: Humalog® (Drug)
结局指标
主要结局
AUCLispro(0-30min)
时间窗: Up to 30 minutes
Area under the insulin lispro serum concentration - time curve from t=0 to 30 minutes
次要结局
- AUCGIR(0-last)(Up to 8 hours)
- Adverse Events(Up to 10 weeks)