NCT05849311已完成1 期
A Randomized, Double-blind, Single-dose, Parallel Controlled Phase I Study to Evaluate the Pharmacokinetics, Safety, and Immunogenicity of Envafolimab in Healthy Male Subjects Before and After the Manufacturing Process Change
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- AUC0-t
研究概览
简要总结
The purpose of this study is to evaluate the pharmacokinetic similarity, safety, and immunogenicity of Envafolimab in healthy male subjects before and after the manufacturing process change.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Be able to fully read, understand, and sign the informed consent form;
- •Male subjects aged 18-45 years
- •Clinical examinations in the screening period are normal or abnormal without clinical significance;
- •A body mass index (BMI) in the range of 19 to 26 kg/m22, and a body weight between 50 and 85 kg;
- •Use effective contraceptive methods from the beginning of the informed consent to 5 months after the use of the drug, and have no plans to give birth or donate sperm.
排除标准
- •Systolic blood pressure ≥140 mmHg/ diastolic blood pressure ≥90 mmHg or systolic blood pressure < 90 mmHg/ diastolic blood pressure < 60 mmHg, pulse > 100 beats /min or < 50 beats /min at screening or baseline examination;
- •QT interval (QTcF) ≥450;
- •Estimated glomerular filtration rate eGFR < 90 ml/min/1.73m2;
- •Thyroid function beyond the normal range;
- •ALT > ULN Or AST > ULN;
- •Prior treatment with a PD-1/L1 inhibitor;
- •Have taken any prescription drug, over-the-counter drug, any vitamin product or herbal or health product within 14 days prior to study drug administration;
- •Had a history of upper respiratory tract infection or other acute infection within 14 days prior to study drug administration;
- •Positive hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus antibody or syphilis.
研究组 & 干预措施
Envafolimab with new manufacturing process
Experimental
80 healthy male subjects with Envafolimab with new manufacturing process
干预措施: Envafolimab with new manufacturing process (Drug)
Envafolimab with old manufacturing process
Active Comparator
80 healthy male subjects with Envafolimab with old manufacturing process
干预措施: Envafolimab with old manufacturing process (Drug)
结局指标
主要结局
AUC0-t
时间窗: From pre-dose to day 85
Area under the plasma concentration-time curve
Cmax
时间窗: From pre-dose to day 85
concentration
次要结局
- Tmax(From pre-dose to day 85)
- AUC0-infinity(From pre-dose to day 85)
- CL(From pre-dose to day 85)
- λz(From pre-dose to day 85)
- t1/2(From pre-dose to day 85)
- Vd(From pre-dose to day 85)
- Safety and tolerance(From pre-dose to day 85)
- Immunogenicity assessment(From pre-dose to day 85)
研究者
研究点 (1)
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