A Single Center, Randomized, Double-Blind, Single Ascending Dose, Crossover Designed Study to Evaluate the Safety, Tolerability and Pharmacokinetics of HR011408 at Two Formulations in Healthy Subject
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Incidence and severity of adverse events (AEs)
研究概览
简要总结
The objective of the study is to assess the safety, tolerability and pharmacokinetics of HR011408 at two formulations in healthy subject.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female aged 18-55 years (both inclusive) at the time of signing informed consent.
- •Body mass index 18.0-26.0kg/m2 (both inclusive).
- •Body weight ≥ 50.0 kg (male),≥ 45.0 kg (female).
- •Fasting serum/plasma glucose < 6.1 mmol/L.
排除标准
- •Known or suspected of being allergic to any ingredient in the study drug.
- •Participated in any drug or medical device-related clinical trial within 3 months before screening.
- •Subjects addicted to smoking, or non-smoker who smoked within 48 hours before administration.
- •Donated blood within 1 month before screening; or donated blood ≥ 400 mL or had blood loss ≥ 400 mL during trauma or major surgery within 3 months before screening.
- •Subjects with incompetence or language impairment, who cannot fully understand or participate in the study.
研究组 & 干预措施
Cohort one: Low dose
Subjects will be randomized to a treatment sequence consisting of two treatment periods: received two formulation HR011408 injections successively
干预措施: HR011408 injection (Drug)
Cohort two: Medium dose
Subjects will be randomized to a treatment sequence consisting of two treatment periods: received two formulation HR011408 injections successively
干预措施: HR011408 injection (Drug)
Cohort three: high dose
Subjects will be randomized to a treatment sequence consisting of two treatment periods: received two formulation HR011408 injections successively
干预措施: HR011408 injection (Drug)
结局指标
主要结局
Incidence and severity of adverse events (AEs)
时间窗: from Day1 to Day15
The incidence of adverse events will be collected and the safety of HR011408 will be assessed
Area under the concentration-time curve (AUC)
时间窗: from 0 to 10 hours after dose administration
Area under the concentration-time curve (AUC)
Maximum observed concentration (Cmax)
时间窗: from 0 to 10 hours after dose administration
Maximum observed concentration (Cmax)
Elimination half-life (t1/2)
时间窗: from 0 to 10 hours after dose administration
Elimination half-life (t1/2)
Time to maximum observed concentration (Tmax)
时间窗: from 0 to 10 hours after dose administration
Time to maximum observed concentration (Tmax)
Onset of appearance
时间窗: from 0 to 10 hours after dose administration
First time point after dose administration when concentration reaches lower limit of quantification (LLOQ)
Time to 50% maximum observed concentration (time to 50% Cmax)
时间窗: from 0 to 10 hours after dose administration
Time to 50% maximum observed concentration (time to 50% Cmax)
次要结局
- Assessment of development of Anti-drug Antibodies (ADAs)(from Day1 to Day15 after dose administration)