Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of JY09, a Long-acting Glucagon-like Peptide-1 Mimetic, in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Incidence of adverse events and serious adverse events related to JY09
研究概览
简要总结
JY09 is a glucagon-like peptide-1 (GLP-1) mimetic generated by genetic fusion of a Exendin-4 dimer to human immunoglobulin Fc.
In this Double-blind, randomized, placebo-controlled trial, 41 healthy subjects received placebo or escalating doses of JY09 on day 1 in the first cohort, and on days 1 and 22 in the following sequential cohort 2-4, and on days 1, 15, and 30 in the cohort 5: cohort 1: 0.3 mg; cohort 2: 0.3 + 0.7 mg; cohort 3: 0.7+1.5 mg; cohort 4: 0.7+3.0 mg; and cohort 5: 0.7 + 1.5 + 6.0 mg. The primary endpoints were the incidence of adverse events and serious adverse events related to JY09. Secondary endpoints included pharmacodynamics and pharmacokinetics parameters, as well as anti-JY09 antibody incidence and titers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects
- •Male's mass is ≥50 kg, female's mass is ≥45 kg, have a body mass index between 18 and 26 kg/m^2
- •Subjects or their legal representative signed informed consent
- •agree to use instruments of contraception from the time of the first dose until 6 months after the last dose of investigational drug, avoid pregnancy make yourself or your mate
- •Able to keep good communication with investigator and comply with the requirements of the clinical trials
排除标准
- •Smokers,quitting time less than 3 months , or can't quit smoking during the trial
- •Use of any prescription drugs within 4 weeks prior dosing, or over-the-counter medication (vitamins, herbal supplements, dietary supplements) within 2 weeks prior to dosing,or being treated for a direct lower gastrointestinal or using steroids
- •Participation in any clinical investigation within 3 months prior to dosing
- •Donation or loss of 400 mL or more of blood within 8 weeks prior to first dosing
- •Significant illness within 2 weeks prior to dosing,and investigator judge doesn't fit to participate in this trial
- •A history of clinical significance of abnormal ECG
- •A history of diabetes, hyperuricemia and hyperlipidemia
- •A history of acute or chronic bronchial spasms
- •Have clinical significant gastrointestinal diseases
- •Have serious, progressive, or uncontrolled organ or system diseases
- •Abuse of drug or alcohol within 12 months before first dosing
- •People who are pregnant, nursing mothers, or in the near future plan to be pregnant,or show pregnancy test positive before into group
- •Subjects who, in the opinion of the investigator, are in any way unsuitable to participate in the study
研究组 & 干预措施
Cohort 0.3-mg
Eligible subjects received 0.3 mg placebo or JY09 on day 1 in this cohort
干预措施: JY09 (Drug)
Cohort 0.7-mg
Eligible subjects received 0.3 mg placebo or JY09 on days 1, and 0.7 mg placebo or JY09 on days 22
干预措施: JY09 (Drug)
Cohort 1.5-mg
Eligible subjects received 0.7 mg placebo or JY09 on days 1, and 1.5 mg placebo or JY09 on days 22
干预措施: JY09 (Drug)
Cohort 3.0-mg
Eligible subjects received 0.7 mg placebo or JY09 on days 1, and 3.0 mg placebo or JY09 on days 22
干预措施: JY09 (Drug)
Cohort 6.0-mg
Eligible subjects received 0.7 mg placebo or JY09 on days 1, and 1.0 mg placebo or JY09 on days 15, and 6.0 mg placebo or JY09 on days 30
干预措施: JY09 (Drug)
结局指标
主要结局
Incidence of adverse events and serious adverse events related to JY09
时间窗: Up to day 21
次要结局
- Immunogenicity(Up To day 42)
- Pharmacodynamics parameters: Cmax(Up To day 42)
- Pharmacodynamics parameters: AUC(Up to day 42)
- Pharmacodynamics parameters: Half-life(Up to day 42)
- Pharmacokinetics parameters(Day 5)