NCT06548945已完成1 期
A Randomized, Double-Blind, Placebo-Controlled, Dose-escalation Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics (PK/PD) of a Single Dose of GZR18 Injection in Obese/Overweight Subjects
Gan and Lee Pharmaceuticals, USA1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2023年4月25日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- TEAE
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled, dose-escalation phase I clinical study. A sequential design is used in this trial with a single dose escalation climb test, to investigate the safety, tolerability, and PK/PD characteristics of GZR18 injection in Chinese obese/overweight subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects sign the informed consent form (ICF) voluntarily.
- •Chinese adult subjects, both male and female.
- •18 to 65 years old (including both ends) at screening.
- •BMI≥26.0 kg/m2 at screening.
- •Stable weight before screening (i.e. self-reported weight change less than 5 kg within 8 weeks before screening).
- •Female subjects have negative serum Human Chorionic Gonadotropin (HCG) during screening and baseline periods.
- •Subjects have good daily habits and can maintain good communication with investigators and comply with various requirements of clinical trials.
排除标准
- •Lactating women.
- •History of fainting with blood and needles.
- •Known or suspected allergy to study related products; or drug/food allergy history; or allergy-related diseases history.
- •Subjects who have participated in other clinical trials and given investigational drugs or medical device interventions within 90 days before screening.
- •History of drug abuse within 1 year before screening, or positive results in drug abuse screening (urine).
- •Smokers who smoke ≥ 5 cigarettes per day within the previous 3 months before screening or cannot refrain from smoking throughout the trial period.
- •Any vaccine has been used within 28 days before administration, as well as any vaccine that may be used throughout the trial period.
- •Other scenarios judged by the investigator to render the subjects unsuitable for participating in this study.
研究组 & 干预措施
GZR18
Experimental
干预措施: GZR18 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Other)
结局指标
主要结局
TEAE
时间窗: 50 days
Incidence of Treatment Emergent Adverse Event(s)
Anti-Drug Antibody (ADA) and Neutralizing Antibody (Nab)
时间窗: 50 days
次要结局
- Cmax(50 days)
- λz(50 days)
- CL/F(50 days)
- AUClast(50 days)
- t1/2(50 days)
- AUC0-inf(50 days)
- Body Mass Index (BMI)(50 days)
- tlag(50 days)
- Vz/F(50 days)
- AUC%extra(50 days)
- MRT(50 days)
- Weight(50 days)
- Tmax(50 days)
研究者
研究点 (1)
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