NCT06548997已完成1 期
A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GZR18 Injection in Healthy Subjects Following Single Dose and Once-weekly Dose for 2 Consecutive Weeks Until Reaching the Target Dose
Gan and Lee Pharmaceuticals, USA1 个研究点 分布在 1 个国家目标入组 57 人开始时间: 2021年12月2日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- TEAE
研究概览
简要总结
This trial is conducted in China. The aim of the trial is to evaluate the safety and tolerability of GZR18 injection in healthy subjects following single dose and once-weekly dose for 2 consecutive weeks until reaching the target dose.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects sign informed consent voluntarily.
- •Chinese adult subjects, male or female.
- •Age 18-55 at screening (both included).
- •At screening and baseline, 19.0 kg/m2 ≤ BMI ≤ 26.0 kg/m2 (male ≥55.0 kg, female ≥45.0 kg).
- •Female subjects were human chorionic gonadotophin (HCG) negative at screening and baseline.
排除标准
- •History of dizziness with blood and needles.
- •Known or suspected allergy to study related products; or a history of drug and food allergies; or a history of allergy-related diseases.
- •Participants who participated in other clinical trials and were given the investigational drug or medical device intervention within 90 days prior to screening.
- •Blood donation, surgery, or trauma with significant blood loss (more than or equal to 400 mL, except for menstrual blood loss in women) within 12 weeks prior to screening.
- •Any clinically significant medical history judged by the investigator, including but not limited to: lung, gastrointestinal, liver, nervous system, kidney, genitourinary and endocrine, skin, or blood disorders, especially a personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 , and a history of pancreatitis (acute or chronic).
- •At screening or baseline, physical examination showed clinically significant abnormalities judged by the investigator.
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: after 28/35 days of treatment
Incidence of treatment-emergent adverse events (TEAE)
次要结局
- AUClast(28/35 days)
- tlag(28/35 days)
- CL/F(28/35 days)
- AUC0-inf(28/35 days)
- AUC%extra(28/35 days)
- AUCglucose0-14h(28/35 days)
- AUCinsulin0-14h(28/35 days)
- body weight(28/35 days)
- Cmax(28/35 days)
- Vz/F(28/35 days)
- MRT(28/35 days)
- λz(28/35 days)
- Tmax(28/35 days)
- t1/2(28/35 days)
- AUCc-peptide0-14h(28/35 days)
- body mass index (BMI）(28/35 days)
研究者
研究点 (1)
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