A Phase I, Randomized, Open-label, Two-Arm, Parallel Group, Single-Dose Study to Compare the Pharmacokinetics, Safety and Immunogenicity of the Auto-injector and Pre-filled Syringe of CT-P43 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
- 162
- 试验地点
- 1
- 主要终点
- PK similarity demonstration by AUC 0-inf
研究概览
简要总结
This is phase 1 study to Compare the Pharmacokinetics, Safety and Immunogenicity of the Auto-injector and Pre-filled syringe of CT-P43 in Healthy Male Subjects.
详细描述
CT-P43, containing the active ingredient ustekinumab, is being developed by CELLTRION, Inc. as a proposed biosimilar to the reference product, Stelara. In this study, Pharmacokinetics, Safety and Immunogenicity of the Auto-injector and Pre-filled syringe of CT-P43 will be 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
- None
入排标准
- 年龄范围
- 19 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 19 and 55 years, both inclusive.
- •Subject has a body weight between 60 to 90 kg, both inclusive, and a 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 hepatitis B virus, hepatitis C virus, human immunodeficiency virus, or syphilis
- •Active or latent Tuberculosis
- •History of malignancy
- •Previous exposure to ustekinumab or a biosimilar of ustekinumab or any drug that directly targets interleukin (IL)-12, IL-17 or IL-23
研究组 & 干预措施
CT-P43 Auto-injector
CT-P43, 45 mg in 0.5 ml, a single subcutaneous (SC) injection via auto-injector (AI)
干预措施: CT-P43 (Biological)
CT-P43 Pre-filled syringe
CT-P43, 45 mg in 0.5 ml, a single SC injection via pre-filled syringe (PFS)
干预措施: CT-P43 (Biological)
结局指标
主要结局
PK similarity demonstration by AUC 0-inf
时间窗: Day113
Demonstrate the PK similarity in terms of area under the concentration-time curve from time zero to infinity (AUC0-inf) of CT-P43 SC administration via AI versus PFS in healthy male subjects up to Day 113 (Week 16).
PK similarity demonstration by Cmax
时间窗: Day113
Demonstrate the PK similarity in terms of maximum serum concentration (Cmax) of CT-P43 SC administration via AI versus PFS in healthy male subjects up to Day 113 (Week 16).
次要结局
- Additional PK evaluation(Day113)
- Safety evaluation by AEs(Day113)