A Study to Assess the Pharmacokinetics, Glucodynamics, Safety, and Tolerability of Single Subcutaneous Injections of Insulin Lispro With BioChaperone Excipient in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Adocia
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Pharmacokinetics: Area under the concentration curve (AUC)
研究概览
简要总结
BC106 is a molecule that when injected with insulin lispro may change the speed of absorption of insulin lispro. The purpose of this study will be to evaluate the safety of BC106 insulin lispro and any side effects that might be associated with it, blood levels of insulin lispro after injection under the skin and how BC106 insulin lispro affects blood sugar after injection under the skin. There is a minimum 7 day washout between single doses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Are not of child-bearing potential
- •Have a body mass index (BMI) between 18 and 29.9 kilograms per square meter (kg/m^2), inclusive
- •Are nonsmokers or have not smoked for at least 6 months prior to entering the study
- •Have a fasting plasma glucose less than 6.0 millimoles per liter (mmol/L) at screening
排除标准
- •Have known allergies to insulin or its excipients, or related drugs, or history of relevant allergic reactions of any origin including allergies to dextrans
- •Have a history of first-degree relatives known to have diabetes mellitus
- •Have used systemic glucocorticoids within 3 months prior to entry into the study
- •Have donated or had a blood loss of 450 milliliters (mL) 3 months prior to study enrollment
研究组 & 干预措施
Insulin Lispro
15 international units (IU) insulin lispro administered once subcutaneously (SC) during 1 of 3 dosing periods. There is a minimum 7 day washout between dosing periods.
干预措施: Insulin Lispro (Drug)
BC106 Insulin Lispro
15 up to 30 IU BC106 insulin lispro administered once SC during 2 of 3 dosing periods. There is a minimum 7 day washout between dosing periods.
干预措施: BC106 insulin lispro (Drug)
结局指标
主要结局
Pharmacokinetics: Area under the concentration curve (AUC)
时间窗: Baseline up to 8 hours post administration of study drug
Pharmacokinetics: Maximum concentration (Cmax)
时间窗: Baseline up to 8 hours post administration of study drug
Pharmacokinetics: Time of maximum concentration (Tmax)
时间窗: Baseline up to 8 hours post administration of study drug
次要结局
- Glucodynamic response: Time to maximum infusion rate (tRmax) during euglycemic clamps of BC106 insulin lispro(Baseline up to 30 days)
- Pharmacokinetics: Within-participant variability of time to maximum drug concentration (tmax) of BC106 insulin lispro(Baseline up to 30 days)
- Glucodynamic within-participant variability of time to maximum glucose infusion rate (tRmax) for BC106 insulin lispro(Baseline up to 30 days)