NCT06548906招募中1 期
A Trial Investigating the Pharmacokinetics, Pharmacodynamics and Safety of GZR4 Injection at Different Injection Regions in Healthy Subjects
Gan and Lee Pharmaceuticals, USA1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2024年5月8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
- 招募中
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- AUC0-672h
研究概览
简要总结
This trial is conducted in China. This study is a randomized, single-center, open, three-period crossover trial in healthy subjects to compare the PK, PD, and safety of a single administration of GZR4 at different injection sites (abdomen, deltoid region of upper arm, and thigh).
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
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Signing the informed consent form (ICF) before the trial, fully understanding the trial content, process and possible adverse reactions, and being able to comply with the contraindications and restrictions specified in this protocol.
- •A Male adult subjects aged 18-55 years old.
- •Body mass index (BMI) between 19.0-24.0 kg/m2
排除标准
- •Known or suspected hypersensitivity to investigational medical product(s) or related products.
- •Participation in a clinical study of another study drug within 3 months prior to randomization.
- •Physical examination, vital signs, laboratory examination, imaging examination, 12-lead electrocardiogram and other auxiliary examination results that the researchers considered abnormal clinical significance during screening.
- •Donation of blood or blood products (more than 100mL) or significant blood loss (more than 200 mL) within 6 months prior to screening
- •More than 14 units of alcohol per week within 3 months prior to randomization
- •Smoking more than 5 cigarettes per day within 3 months prior to randomization
研究组 & 干预措施
GZR4 Injection- Abdomen
Experimental
Participants received GZR4 Injection by subcutaneous injection on Abdomen.
干预措施: GZR4 Injection (Drug)
GZR4 Injection- Upper Arm
Experimental
Participants received GZR4 Injection by subcutaneous injection on Upper Arm.
干预措施: GZR4 Injection (Drug)
GZR4 Injection- Thigh
Experimental
Participants received GZR4 Injection by subcutaneous injection on Thigh.
干预措施: GZR4 Injection (Drug)
结局指标
主要结局
AUC0-672h
时间窗: From Predose to 672 hours after a single dose
Area Under the Concentration Versus Time Curve of GZR4 Injection From Time Zero to 672 hours
次要结局
- AUC0-∞(From Predose to 672 hours after a single dose)
- Cmax(From Predose to 672 hours after a single dose)
研究者
研究点 (1)
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