A Phase 1, Randomized, Double-blind, Three-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics, Safety and Immunogenicity of CT-P55, EU-approved Cosentyx and US-licensed Cosentyx in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Celltrion
- 入组人数
- 172
- 试验地点
- 4
- 主要终点
- Pharmacokinetic (PK) similarity demonstration in terms of area under the concentration-time curve (AUC) from time zero to infinity (AUC0-inf)
研究概览
简要总结
This is a Phase 1, Randomized, Double-blind, three-arm, Parallel group, Single-dose Study to Compare the Pharmacokinetics, Safety and immunogenicity of CT-P55, EU-approved Cosentyx and US-licensed Cosentyx in Healthy male Subjects
详细描述
CT-P55, containing the active ingredient secukinumab, is being developed by CELLTRION, Inc. as a proposed biosimilar to the reference product, Cosentyx. In this study, Pharmacokinetics, Safety and Immunogenicity of CT-P55, EU-approved Cosentyx and US-licensed Cosentyx were evaluated in Healthy Male Subjects.
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 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male subjects between the ages of 18 and 55 years, both inclusive.
- •Body weight between 50.0 kg and 90.0 kg (both inclusive), and Body Mass Index (BMI) between 18.5 and 29.9 kg/m2 (both inclusive), when rounded to the nearest tenth.
排除标准
- •A medical history and/or condition that is considered significant
- •Clinically significant allergic reactions, hypersensitivity
- •History or current infection of human immunodeficiency virus, hepatitis B virus, hepatitis C virus or syphilis
- •Active or latent Tuberculosis
- •History of malignancy
- •Previous monoclonal antibody or fusion protein treatment, or current use of any biologics
- •Planning to be father a child or donate sperm within 22 weeks period following study drug administration.
- •Undergone treatment with an investigational drug or participated in another clinical trial within 12weeks or 5 half-lives (whichever is longer)
研究组 & 干预措施
CT-P55
a single subcutaneous (SC) injection via pre-filled syringe (PFS)
干预措施: CT-P55 (Biological)
US-licensed Cosentyx
a single SC injection via PFS
干预措施: US-licensed Cosentyx (Biological)
EU-approved Cosentyx
a single SC injection via PFS
干预措施: EU-approved Cosentyx (Biological)
结局指标
主要结局
Pharmacokinetic (PK) similarity demonstration in terms of area under the concentration-time curve (AUC) from time zero to infinity (AUC0-inf)
时间窗: Day 155
Demonstrate PK similarity in terms of area under the concentration-time curve (AUC) from time zero to infinity (AUC0-inf) of CT-P55, European Union (EU)-approved Cosentyx and United States (US)-licensed Cosentyx in healthy male subjects. The similarity of PK will be concluded if the 90% Cls for the ratios of geometric means of the comparison are entirely contained within the equivalence margin of 80% to 125% for AUC0-inf.
PK similarity demonstration in terms of maximum serum concentration (Cmax)
时间窗: Day 155
Demonstrate PK similarity in terms of Cmax of CT-P55, EU-approved Cosentyx and US-licensed Cosentyx in healthy male subjects up to Day 155. The similarity of PK will be concluded if the 90% Cls for the ratios of geometric means of the comparison are entirely contained within the equivalence margin of 80% to 125% for Cmax.
次要结局
- Evaluate additional PK in terms of AUC from time zero to the last quantifiable concentration (AUC0-last)(Day 155)
- Evaluate additional PK in terms of Time to Cmax (Tmax)(Day155)
- Evaluate additional PK in terms of Apparent volume of distribution during the terminal phase after non-intravenous administration (Vz/F)(Day 155)
- Evaluate additional PK in terms of Terminal elimination rate constant (λz)(Day155)
- Evaluate additional PK in terms of Terminal elimination half-life (t1/2)(Day 155)
- Evaluate additional PK in terms of Apparent total body clearance (CL/F)(Day155)
- Evaluate additional PK in terms of Percentage of the area extrapolated for calculation of AUC0-inf (%AUCextrap)(Day 155)
- Evaluate safety in terms of treatment-emergent adverse events (TEAEs) of CT-P55 as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0.(Day 155)