A (Randomised, Double-Blind, Intravenous Single-Dose, Parallel, Four-Arm) Phase I Clinical Study to Compare Pharmacokinetics, Safety, and Immunogenicity of HLX11 vs. Perjeta® (US, EU, and CN-Sourced) in Healthy Chinese Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Cmax
研究概览
简要总结
This is a randomised, double-blind, intravenous single-dose, four-arm parallel study designed to compare the PK of HLX11 and US, EU, and CN-sourced Perjeta® in healthy Chinese adult male subjects, and to assess the safety, tolerability, and immunogenicity of these 4 drugs.
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
- Double (Participant, Investigator)
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
- •Healthy Chinese males
- •aged ≥ 18 and ≤ 45
- •body mass index (BMI) ≥ 19 and ≤ 26 kg/m2
- •LVEF≥ 55%
排除标准
- •A history of any serious clinical disease such as haematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, mental, neurological diseases, and tumour, or allergic diseases
- •Use of a monoclonal antibody or any biological product within 6 months before study drug administration
- •A history of allergic reactions or anaphylaxis, including such reactions to any drug or excipient in the clinical study
- •Use of prescription drugs, over-the-counter drugs (OTC), or traditional Chinese medicine (TCM) (excluding vitamins, mineral supplements, and dietary supplements) within 28 days before study drug administration
- •A history of blood donation within 3 months before study drug administration
- •Participation in other clinical study and use of the investigational product/comparator within 3 months before study drug administration
- •Positive for hepatitis B surface antigen (HbsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody, or treponema pallidum antibody
- •A history of drug abuse
- •Failure to comply with protocol requirements, instructions, and study limitations, such as uncooperative attitude, failure to return to the study site for follow-up visits, or failure to complete the entire clinical study, as judged by investigators
研究组 & 干预措施
HLX11 group
HLX11 are given intravenous infusion at a single dose of 420 mg, and the administration time is 60 min (± 10 min).
干预措施: HLX11 (Drug)
CN-Perjeta group
CN-Perjeta are given intravenous infusion at a single dose of 420 mg, and the administration time is 60 min (± 10 min).
干预措施: CN-Perjeta(Pertuzumab) (Drug)
EU-Perjeta group
EU-Perjeta are given intravenous infusion at a single dose of 420 mg, and the administration time is 60 min (± 10 min).
干预措施: EU-Perjeta(Pertuzumab) (Drug)
US-Perjeta group
US-Perjeta are given intravenous infusion at a single dose of 420 mg, and the administration time is 60 min (± 10 min).
干预措施: US-Perjeta(Pertuzumab) (Drug)
结局指标
主要结局
Cmax
时间窗: from predose to 2352 hours (Day 99),13 timepoints
Peak concentration
AUC0~inf
时间窗: from predose to 2352 hours (Day 99),13 timepoints
Area under the plasma concentration-time curve from time 0 to infinity
AUC0~t
时间窗: from predose to 2352 hours (Day 99),13 timepoints
Area under the plasma concentration-time curve from time 0 to the last concentration-measurable time point
次要结局
- safety and tolerability of two groups(from day1 to day 99)
- safety and tolerability of 4 groups(from day1 to day 99)