NCT05738993进行中（未招募）1 期
A Double-Blind, Comparative, Randomized Clinical Study of the Pharmacokinetics, Safety, and Immunogenicity of a Single Intravenous Infusion of BCD-178 or Perjeta® in Healthy Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Biocad
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- AUC0-∞
研究概览
简要总结
This is a double-blind, comparative, randomized phase I study comparing pharmacokinetics, safety and immunogenicity profiles of a biosimilar pertuzumab (BCD-178) and Perjeta after a single intravenous infusion in healthy male volunteers
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
- •Signed informed consent;
- •Men aged 18-45 years;
- •Body mass index (BMI) in the range of 18.5 30.0 kg/m2;
- •The confirmed "healthy" status;
- •Left ventricular ejection fraction (LVEF) > 50 % based on the results of EchoCG at screening;
- •Willingness of the volunteers and their sexual partners of childbearing potential to use reliable methods of contraception, starting from signing the informed consent form, during the study, and for 6 months after the drug administration;
排除标准
- •Known allergy or intolerance to monoclonal antibody products (murine, chimeric, humanized, fully human) or any other components of the study drugs;
- •Values of standard laboratory and instrumental parameters exceeding the normal limits accepted at the study site;
- •History or evidence of any chronic disease
研究组 & 干预措施
BCD-178 group
Experimental
single IV infusion of BCD-178 at a dose of 420 mg
干预措施: BCD-178 (Drug)
Perjeta Group
Active Comparator
single IV infusion of Perjeta at a dose of 420 mg
干预措施: Perjeta (Drug)
结局指标
主要结局
AUC0-∞
时间窗: pre-dose to day 91, 23 timepoints
Area under the concentration-time curve of the drug over the time interval from zero to infinity
次要结局
- Cmax(pre-dose to day 91, 23 timepoints)
- Tmax(pre-dose to day 91, 23 timepoints)
- T½(pre-dose to day 91, 23 timepoints)
- CL(pre-dose to day 91, 23 timepoints)
- Kel(pre-dose to day 91, 23 timepoints)
- Vd(pre-dose to day 91, 23 timepoints)
- safety assessment(Day 1 to day 91)
- immunogenicity assessment(pre-dose to day 91, 5 timepoints)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
1 期
Biosimilar Study Comparing PK, PD, Safety and Immunogencity of BP11 With US Licensed Xolair and EU Approved XolairHealthy VolunteersNCT05053334Syneos Health165
已完成
1 期
PK and Safety of SCT510HealthyNCT05113511First Affiliated Hospital of Zhejiang University84
已完成
1 期
Comparative Study of Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of Single Intravenous Doses of BCD-148 and Soliris®Healthy SubjectsNCT04027803Biocad78
进行中（未招募）
1 期
Study, Evaluating Pharmacokinetics, Pharmacodynamics, Immunogenicity and Safety Profiles of Rituximab Compared to MabThera® in Patients With Rheumatoid ArthritisRheumatoid ArthritisNCT06175338Mabscale, LLC208
撤回
2 期
Pharmacokinetics, Efficacy, Tolerability and Safety of Different Budesonide Oral Gel Doses in Adults' Subjects of Both Genders With Eosinophilic Esophagitis (EoE)Eosinophilic EsophagitisNCT05214599Bazell Pharma AG