Bioequivalence Study of GZR4 Injection With Different Manufacturing Processes in Healthy Adult Participants
A Randomized, Open-label, Single-dose Study to Evaluate the Bioequivalence of GZR4 Injection With Different Manufacturing Processes in Healthy Adult Participants
研究概览
研究类型
注册 (估计的)
阶段
- 阶段1
联系人和位置
学习联系方式
- 姓名:Yunda Zhuge
- 电话号码:010-56456739
- 邮箱:zhugeyunda@ganlee.com
研究联系人备份
- 姓名:Shiyun Lai
- 电话号码:010-56456739
- 邮箱:shiyun.lai@ganlee.com
学习地点
-
-
Shandong
-
Linyi、Shandong、中国、276000
- Gan & Lee Pharmaceuticals Shandong Co., Ltd.,
-
接触:
- Yunda Zhuge
- 电话号码:010-56456739
- 邮箱:zhugeyunda@ganlee.com
-
-
参与标准
资格标准
适合学习的年龄
- 成人
接受健康志愿者
描述
Inclusion Criteria:
1. Voluntarily sign the Informed Consent Form (ICF), be willing to accept subcutaneous injection, fully understand the study content, procedures and potential adverse reactions, and be able to comply with the contraindications and restrictions specified in this protocol.
2. Male, aged 18 to 50 years (inclusive) at the time of ICF signing. 3. Body weight ≥ 50 kg and body mass index (BMI) within the range of 18.5 to 24.0 kg/m² (inclusive) at screening.
4. Male participants of childbearing potential have no plans for conception, voluntarily adopt effective contraceptive measures, and have no sperm donation plans from the date of ICF signing until 4 weeks after dosing.
Exclusion Criteria:
1. Have an allergic constitution, or a history of allergic diseases such as bronchial asthma and eczema (except for mild seasonal allergy); or have a history of severe food allergy (e.g., laryngeal edema, shock); or known allergy, hypersensitivity or intolerance to the investigational medicinal product (IMP) or similar products or their excipients; or have a clinically significant history of drug allergy or atopic allergic diseases.
2. Findings from physical examination, vital signs, routine laboratory tests, 12-lead electrocardiogram (ECG), chest imaging and other assessments at screening are judged to be clinically significant by the investigator.
3. Have special dietary requirements and are unable to comply with the standardized diet.
4. Have a history of needle phobia or blood phobia, have difficulty in blood collection, or cannot tolerate venous puncture for blood sampling.
5. The participant is an employee of the investigator or the study center, or a family member of an employee or the investigator; or the participant has other factors that, in the investigator's opinion, make him/her unsuitable for participation in the study.
学习计划
研究是如何设计的?
设计细节
- 主要用途:其他
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:GZR4 injection A
|
GZR4 s.c., single-dose
|
|
实验性的:GZR4 injection B
|
GZR4 s.c., single-dose
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Cmax
大体时间:Day1-Day29
|
Peak concentration following single administration of GZR4
|
Day1-Day29
|
|
AUC₀-t
大体时间:Day1-Day29
|
Area under the plasma concentration-time curve from time zero to the last quantifiable sampling time point t after single administration of GZR4
|
Day1-Day29
|
|
AUC₀-∞
大体时间:Day1-Day29
|
Area under the plasma concentration-time curve from time zero to infinity after single administration of GZR4
|
Day1-Day29
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
最高温度
大体时间:第1天-第29天
|
第1天-第29天
|
|
t1/2
大体时间:Day1-Day29
|
Day1-Day29
|
|
AUC_%Extrap
大体时间:Day1-Day29
|
Day1-Day29
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- GZR4-T2D-106
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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