NCT07670897尚未招募1 期
A Randomized, Open-label, Single-dose Study to Evaluate the Bioequivalence of GZR4 Injection With Different Manufacturing Processes in Healthy Adult Participants
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Cmax
研究概览
简要总结
This study is a single-center, open-label, randomized, single-dose bioequivalence trial conducted in healthy adult participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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.
- •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.
排除标准
- •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.
结局指标
主要结局
Cmax
时间窗: Day1-Day29
Peak concentration following single administration of GZR4
AUC₀-t
时间窗: 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
AUC₀-∞
时间窗: Day1-Day29
Area under the plasma concentration-time curve from time zero to infinity after single administration of GZR4
次要结局
- Tmax(Day1-Day29)
- t1/2(Day1-Day29)
- AUC_%Extrap(Day1-Day29)
研究者
研究点 (1)
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