NCT05005455已完成1 期
A Randomized, Double-blind, Parallel Controlled, Single-dose Phase I Clinical Study to Evaluate Pharmacokinetic Similarity, Safety, and Immunogenicity of Bevacizumab With Different Manufacturing Process in Healthy Male Subjects
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
- 100
- 试验地点
- 1
- 主要终点
- Primary Outcome Measure:Area Under the Curve(AUC0-∞)
研究概览
简要总结
The purpose of this study is to evaluate the pharmacokinetic similarity of bevacizumab with different manufacturing process in healthy male subjects. Another purpose is to determine safety, and immunogenicity of bevacizumab with different manufacturing process.
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 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Sign the informed consent form and fully understand the test content, process and possible adverse reactions, and be able to complete the study according to the test plan requirements;
- •Age≥18 years and ≤50 years, healthy male subjects;
- •Weight ≥ 50kg and ≤ 100kg,BMI≥ 19kg/m2 and < 28 kg/m2
- •Clinical examinations in the screening period are normal or abnormal without clinical significance.
- •Agree to take effective contraceptive measures throughout the study period and until at least 6 months after receiving the last dose of study drug
排除标准
- •Any prior VEGF(vascular endothelial growth factor) and VEGFR(Vascular Endothelial Growth Factor Receptor) antibody or protein treatment within one year.
- •Serious, non-healing wound, active ulcer, or untreated bone fracture, or major surgical procedure within 2 months prior to randomization or anticipation of need for major surgery during the course of the study or 2 months after end of the study.
- •Use Rx or OTC drugs or nutritional health products within 5 half-lives or within 2 weeks before the first dose of study drug (According to the longer time).Herbal supplements need to stop at 28 days before the first dose of study drug.
- •Positive hepatitis b surface antigen (HBsAg), hepatitis c virus (HCV) antibody, or human immunodeficiency virus (HIV) antibody or syphilis.
- •Known hypersensitivity to bevacizumab or any excipients, known allergic disease or allergic constitution.
- •History of blood donation within 3 months before the first dose of study drug.
- •Treatment with any other investigational agent or participation in another clinical trial within 3 months prior to screening.
研究组 & 干预措施
bevacizumab with old manufacturing process.
Active Comparator
干预措施: bevacizumab with old manufacturing process. (Drug)
bevacizumab with new manufacturing process.
Experimental
干预措施: bevacizumab with new manufacturing process. (Drug)
结局指标
主要结局
Primary Outcome Measure:Area Under the Curve(AUC0-∞)
时间窗: 84days
次要结局
- Area Under the Curve(AUClast)(84days)
- Maximum Concentration (Cmax)(84days)
- Volume of distribution (V)(84days)
- Total body clearance (CL)(84days)
- Elimination half-life (t1/2)(84days)
- Time at which maximum concentration occurred (Tmax)(2016days)
- Incicende of Adverse Events (AEs)(98days)
- Anti-drug Antibody（ADA）and Neutralizing Antibody（NAb）(98days)
研究者
研究点 (1)
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