NCT07200986进行中（未招募）1 期
A Phase 1, Randomized, Double-blind, Two-arm, Parallel-Group, Single-dose Study to Compare Pharmacokinetics and Safety of CT-P52 and US-licensed Taltz in Healthy Subjects
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Celltrion
- 入组人数
- 218
- 试验地点
- 5
- 主要终点
- AUC0-inf
研究概览
简要总结
This study is designed to demonstrate PK similarity of the proposed biosimilar test product CT-P52 and the reference product, US-licensed Taltz.
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
- 19 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female subjects between the ages of 19 to 55 years, both inclusive.
- •Subject with a body weight of ≥60 and ≤90 kg for male and ≥50 and ≤90 kg for female, and a BMI between 18.0 and 29.9 kg/m2 (both inclusive) when rounded to the nearest tenth.
- •Subject is able to understand and to comply with protocol requirements, instructions, and restrictions.
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
- •Previous monoclonal antibody or fusion protein treatment, or current use of any biologics
- •Plans to donate whole blood or blood components during the study
- •Male subject who is planning to have child or donate sperms within 10 weeks after the study drug administration. Female subject who is currently pregnant or lactating, or planning to be pregnant or to breastfeed within 10 weeks after the administration of the study drug
- •Reasonable evidence or history of drug/alcohol/smoking abuse
- •Presence of tattoos, sunburn, or other skin disturbances on the injection site
- •Vulnerable subject
研究组 & 干预措施
CT-P52
Experimental
80 mg (single dose), subcutaneous (SC) injection via pre-filled syringe (PFS)
干预措施: Ixekizumab (Biological)
United States (US)-licensed Taltz
Active Comparator
80 mg (single dose), subcutaneous (SC) injection via pre-filled syringe (PFS)
干预措施: Ixekizumab (Biological)
结局指标
主要结局
AUC0-inf
时间窗: Day 85
Pharmacokinetic (PK) similarity demonstration in terms of area under the concentration-time curve (AUC) from time zero to infinity (AUC0-inf)
Cmax
时间窗: Day 85
PK similarity demonstration in terms of maximum serum concentration
次要结局
未报告次要终点
研究者
研究点 (5)
Loading locations...
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