NCT04439929已完成1 期
A Randomized, Double-blind, Two-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics, Safety, Tolerability, and Immunogenicity of Two Formulations of Adalimumab (TUR01 and EU Sourced Humira®) in Healthy Subjects
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 168
- 试验地点
- 2
- 主要终点
- Area under the concentration-time curve from time 0 to infinity (AUCinf)
研究概览
简要总结
This is a randomized, double-blind, two-arm, parallel group, single-dose study to demonstrate pharmacokinetic, safety, tolerability and immunogenicity similarity of biosimilar candidate TUR01 to EU-sourced Humira® in healthy participants after administration of adalimumab.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy female subjects of non-childbearing potential or healthy male subjects aged 18 to 55 years (inclusive at screening).
- •Have body weight between 65.0 to 90.0 kg and a body mass index between 20.0 to 29.9 kg/m2, inclusive.
- •Must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
- •Must be able to provide written informed consent, which must be obtained prior to any study related procedures.
排除标准
- •Evidence or history of clinically significant or relevant pathology.
- •Have either active or latent tuberculosis.
- •Have received treatment with a monoclonal antibody or fusion protein within 9 months prior to administration and/or have evidence of immunogenicity from previous exposure to a monoclonal antibody or fusion protein.
- •Have a mental disease classified as serious by the Investigator.
- •Have received live vaccine(s) within 4 weeks prior to Screening or who will require live vaccine(s) between Screening and the final study visit.
- •Who intake alcoholic beverages more than 28 units per week.
- •Have taken medication with a half-life of > 24 h within 4 weeks or 10 half-lives of the medication prior to investigational medicinal product administration.
- •Have donated > 100 mL of blood or plasma within 4 weeks prior to investigational medicinal product administration.
- •Have participated in another study with an investigational drug within 4 weeks prior to investigational medicinal product administration. Subjects who have received treatment with a biological or immunosuppressive agent within 3 months of screening should also be excluded.
- •Subjects who are not able to consume standardized meals provided by the clinical study site during hospitalization.
- •Subjects who, in the opinion of the Investigator, are not likely to complete the study for whatever reason.
- •Involvement of any sponsor, study site/contract research organisation employee, Investigator or their close relatives.
- •Vulnerable subjects.
- •Pregnant or nursing women.
结局指标
主要结局
Area under the concentration-time curve from time 0 to infinity (AUCinf)
时间窗: Day 1 - Day 71
AUCinf = area under the concentration-time curve from time zero to the last quantifiable concentration (AUClast) + last observed concentration (Ct)/terminal rate constant (λz)
Maximum serum concentration (Cmax)
时间窗: Day 1 - Day 71
Cmax
次要结局
- Area under the concentration-time curve from time zero to the last quantifiable concentration (AUClast)(Day 1 - Day 71)
- Area under the concentration-time curve from time zero to 336 hours (AUC336)(Day 1 - Day 15)
- Time to Cmax (Tmax)(Day 1 - Day 71)
- Terminal half-life calculated by ln(2)/λz (t½)(Day 1 - Day 71)
- Area under the concentration-time curve from time zero to 1680 hours (AUC1680)(Day 1 - Day 71)
- Apparent total body clearance (CL/F)(Day 1 - Day 71)
- Apparent volume of distribution based on the terminal phase (Vz/F)(Day 1 - Day 71)
- Terminal rate constant (λz)(Day 1 - Day 71)
- Area under the concentration-time curve from time zero to 672 hours (AUC672)(Day 1 - Day 29)
- Area under the concentration-time curve extrapolated from time t to infinity as a percentage of total AUC (%AUCextrap)(Day 1 - Day 71)
- Area under the concentration-time curve from time zero to 1008 hours (AUC1008)(Day 1 - Day 43)
研究者
研究点 (2)
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