A Trial Investigating the Pharmacodynamics of BC Combo THDB0207 Compared With Humalog® Mix25 and Simultaneous Injections of Humalog® and Lantus® in Healthy Chinese Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Adocia
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- AUCGIR 0-2h
研究概览
简要总结
This is a randomised, double-blind, double-dummy, active-controlled, three-period crossover euglycemic clamp trial in healthy Chinese volunteers.
Each subject will be randomly allocated to one of 6 treatment sequences. Each sequence comprises one single dose of BC Combo THDB0207, one single dose of Humalog® Mix25, or simultaneous administration of Humalog® and Lantus®.
Subjects will come in a fasted state to the clinical trial centre in the morning of each dosing day and stay at the clinical trial centre until the 30-hour clamp procedures have been terminated.
详细描述
Subjects will attend the study site in the morning in a fasted state and will be connected to an automated glucose clamp device (ClampArt). Prior to dose administration plasma glucose will be stabilised at a defined target level by means of an intravenous infusion of glucose or insulin. IMP administration will be done by an unblinded person by means of subcutaneous injections in the abdominal wall.
Following each dosing a euglycaemic glucose clamp procedure will be carried out for up to 30 hours.
The pharmacodynamic assessment will be based on the time course of glucose infusion rate (GIR) and plasma glucose.
Plasma insulin concentrations will be measured using a specific validated bioanalytical method differentiating concentrations of insulin glargine, of its main metabolites insulin-glargine-M1 and insulin-glargine M2, and of insulin lispro. Pharmacokinetic insulin assessments will be based on total insulin concentration.
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
- Double (Participant, 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
- •Subjects with Chinese origin. To qualify as a subject of Chinese origin (first-generation Chinese), the subject, the subject's biological parents, and all of the subject's biological grandparents are of exclusive Chinese descent and have been born in China.
- •BMI between 18.5 and 30.0 kg/m2, both inclusive.
- •Fasting plasma glucose concentration <= 5.6 mmol/L (100 mg/dL).
排除标准
- •Known or suspected hypersensitivity to IMP(s) or any of the excipients or to any component of the IMP formulation.
- •Receipt of any investigational medicinal product within 3 months before randomisation in this trial.
- •Women of childbearing potential who are not using a highly effective contraceptive method.
- •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.
- •Heart rate at rest outside the range of 50-90 beats per minute.
- •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
BC Combo THDB0207
Single administration of BC Combo THDB0207
干预措施: Euglycemic clamp with BC Combo THDB0207 (Drug)
Humalog® Mix25
Single administration of Humalog® Mix25
干预措施: Euglycemic clamp with Humalog® Mix25 (Drug)
Humalog® and Lantus®
Simultaneous administration of Humalog® and Lantus®
干预措施: Euglycemic clamp with Humalog® and Lantus® (Drug)
结局指标
主要结局
AUCGIR 0-2h
时间窗: From t=0 to t=2 hours after IMP administration
Area under the glucose infusion rate curve until 2 hours after IMP dosing
次要结局
- AUCGIR 0-last(From t=0 to t= 30 hours after IMP administration)
- GIRmax(From t=0 to t= 30 hours after IMP administration)
- AUCGIR 0-1h(From t=0 to t=1 hours after IMP administration)
- AUCGIR 0-6h(From t=0 to t=6 hours after IMP administration)
- AUCGIR 0-24h(From t=0 to t=24 hours after IMP administration)
- tGIRmax(From t=0 to t=30 hours after IMP administration)
- tonset of action(From t=0 to t=30 hours after IMP administration)
- Adverse Events(From the first IMP administration to the follow-up visit (i.e. up to 11 weeks))
- Serious Adverse Events(From the first IMP administration to the follow-up visit (i.e. up to 11 weeks))
- Local tolerability(From the first IMP administration to the follow-up visit (i.e. up to 11 weeks))
- AUCINSlast(From t=0 to t=30 hours after IMP administration)
- AUCINS 0-2h(From t=0 to t=2 hours after IMP administration)
- AUCINS 0-6h(From t=0 to t=6 hours after IMP administration)
- AUCINS 2-4h(From t=2 to t=4 hours after IMP administration)
- AUCINS 6-12h(From t=6 to t=12 hours after IMP administration)
- AUCINS 12-30h(From t=12 to t=30 hours after IMP administration)
- AUCINS 0-30h(From t=0 to t=30 hours after IMP administration)
- CmaxINS(From t=0 to t= 30 hours after IMP administration)
- Tonset ins(From t=0 to t=30 hours)