NCT04670796已完成1 期
A Phase I Study to Compare the Pharmacokinetics, Safety, Tolerability, and Immunogenicity Between HLX02 and Herceptin® (US-licensed and EU-approved Reference Products, Double-blind, Randomized, Parallel-group Part) in Healthy Chinese Male Subjects
Shanghai Henlius Biotech1 个研究点 分布在 1 个国家目标入组 111 人开始时间: 2021年3月2日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 111
- 试验地点
- 1
- 主要终点
- Area under the concentration-time curve from time zero to infinity (AUCinf)
研究概览
简要总结
Randomised, double-blind, parallel group Phase I study to compare PK profiles and to assess the safety and immunogenicity between HLX02 and Herceptin® (U.S. and EU).
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 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Voluntarily signed Informed Consent Form
- •Healthy Chinese male (healthy is defined as the fact that no clinically significant abnormalities are identified by medical history, physical examination, vital signs, chest X ray, 12-lead ECG and laboratory tests)
- •Aged ≥ 18 and ≤ 45 years
- •Body mass index (BMI) ≥ 19 and ≤ 28 kg/m2
- •Body weight ≥ 50 and ≤ 80 kg
- •LVEF within normal range as examined through echocardiogram within 14 days prior to randomization (>50%)
- •Immunogenicity (anti-drug [anti-trastuzumab] antibody [ADA]) tested as negative
- •Subject agrees that he and his female spouse/partner use reliable contraceptive methods from the time of administration of study drug until 3 months after the end of study, or subject is infertile
排除标准
- •Any clinically serious disease history or allergic disease, such as hematologic, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, mental and nervous diseases and tumor
- •Use of monoclonal antibodies or any biological agent within 6 months prior to the administration of the study drug
- •History of allergic reactions, including allergic reactions caused by any drug or excipient in clinical study
- •Use of any prescription or non-prescription drug or dietary supplement within 5 half lives of such drug or dietary supplement or 2 weeks prior to the administration of the study drug (whichever is longer). The traditional Chinese medicine-based dietary supplement should be discontinued 28 days prior to administration of the study drug
- •Donation of blood within 3 months prior to the administration of the study drug
- •Participation in other clinical studies within 3 months prior to the administration of the study drug
- •Positive test result(s) for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody and treponema pallidum
- •History of drug abuse
- •Inability to follow the protocol requirements, instructions and study limitations as judged by investigators, such as noncooperation, inability to return to the site for follow-up visits or inability to complete the whole clinical study
- •Subject confirmed SARS-CoV-2 infection by appropriate test (including but not limited to nucleic acid test) in screening period
研究组 & 干预措施
HLX02
Experimental
patient receive one dose of HLX02
干预措施: HLX02 (Drug)
EU-sourced Trastuzumab (Herceptin®)
Active Comparator
patient receive one dose of EU-sourced Trastuzumab (Herceptin®)
干预措施: EU-sourced Trastuzumab (Herceptin®) (Drug)
US-licensed Trastuzumab (Herceptin®)
Active Comparator
patient receive one dose of US-licensed Trastuzumab (Herceptin®)
干预措施: US-licensed Trastuzumab (Herceptin®) (Drug)
结局指标
主要结局
Area under the concentration-time curve from time zero to infinity (AUCinf)
时间窗: 57 days
次要结局
- Maximum serum concentration (Cmax)(57 days)
- time to Cmax (Tmax)(57 days)
研究者
研究点 (1)
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