NCT05765357已完成1 期
Phase I Clinical Study of Randomized, Double-blind, Single-dose, Parallel Comparison of Trastuzumab for Injection and Herceptin® in Healthy Male Volunteers on Pharmacokinetics and Safety
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
- 89
- 试验地点
- 1
- 主要终点
- Area under drug concentration - time curve (AUC0-t)
研究概览
简要总结
Trastuzumab for injection is a biosimilar of Herceptin ® produced by Chia Tai Tianqing Biotechnology Co., LTD, which is a humanized IgG1 monoclonal antibody produced by chinese hamster ovary (CHO) cells. A randomized, double-blind, single-dose, parallel phase I study comparing trastuzumab for injection with Herceptin ® in healthy male volunteers was conducted to evaluate the similarities in pharmacokinetics, tolerability, safety and immunogenicity of Trastuzumab for injection and Herceptin®.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Fully understand the purpose of the trial, and have a basic understanding of the pharmacological effects and possible adverse reactions of the drug under study; Voluntary written informed consent in accordance with the Helsinki Declaration;
- •Healthy male subjects aged ≥ 18 years and ≤ 65 years;
- •Body weight ≥ 50 kg ≤ 90 kg, body mass index ≥ 18 ≤ 28kg/m2;
- •The system examination indicators were within the normal range, or the examination results were abnormal but the researchers judged that there was no clinical significance;
- •Subjects agree to use reliable contraceptive methods for both themselves and their partners during the study period and for 6 months after the study drug infusion.
排除标准
- •History of hypertension or abnormal blood pressure at screening/baseline measurement;
- •A history of albuminuria or albuminuria as assessed by the investigator as clinically significant;
- •Received any antibody or protein targeting Vascular Endothelial Cell Growth Factor (VEGF) or VEGF receptors in the previous 1 year;
- •Study the use of any biological product or live virus vaccine within 3 months prior to drug infusion, or the use of any monoclonal antibody within 12 months;
- •Have an inherited tendency to bleed or have coagulation dysfunction, or have a history of thrombosis or bleeding;
- •History of digestive tract perforation or digestive tract fistula;
- •Unhealed wound ulcers or fractures, or major surgery within 2 months prior to randomization or expected to be performed during the study period or within 2 months after study completion;
- •Use of a prescription or over-the-counter drug or nutritional supplement within the 5 half-life of the drug or nutritional supplement or within 2 weeks prior to the study drug use;
- •Positive virology test;
- •Known allergy to trastuzumab;
- •Known history of allergic diseases or allergic constitution;
- •Study the history of blood donation 3 months before drug infusion;
- •Received any other investigational drug therapy or participated in another interventional clinical trial within 2 months prior to screening
- •A history of alcohol or drug abuse in the 12 months prior to screening;
- •A history of mental illness;
- •Subjects whose spouses plan to become pregnant;
- •The study cannot be completed according to protocol requirements during the study period;
- •Conditions considered unsuitable for inclusion by other researchers.
研究组 & 干预措施
Trastuzumab for injection
Experimental
4mg/kg, Single dose for intravenous infusion
干预措施: Trastuzumab for injection (Drug)
Herceptin
Active Comparator
4mg/kg, Single dose for intravenous infusion
干预措施: Herceptin (Drug)
结局指标
主要结局
Area under drug concentration - time curve (AUC0-t)
时间窗: Within 30 minutes before administration to 1344 hours after administration
Area under the curve from time zero to the lowest detectable blood drug concentration
次要结局
- Time to reach maximum plasma (Tmax)(Within 30 minutes before administration to 1344 hours after administration)
- Area under drug concentration - time curve (AUC0-∞)(Within 30 minutes before administration to 1344 hours after administration)
- Peak concentration (Cmax)(Within 30 minutes before administration to 1344 hours after administration)
- Apparent volume of distribution (Vd/F)(Within 30 minutes before administration to 1344 hours after administration)
- half-life (T1/2)(Within 30 minutes before administration to 1344 hours after administration)
- Clearance (CL)(Within 30 minutes before administration to 1344 hours after administration)
研究者
研究点 (1)
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