Phase 1, Double Blind, Randomized, Parallel-group, Single-dose, Comparative Pharmacokinetic, Safety, Tolerability Study of Exemptia (Adalimumab) injection, solution for subcutaneous use (40 mg/0.8 ml.) with HumiraÂ® (Adalimumab) injection, solution for subcutaneous use(40mg/0.8ml) administered to healthy subjects.

RusBiopharm LLC Russia0 个研究点目标入组 100 人开始时间: 待定最近更新: 2021年11月24日

研究概览

暂无简介。

•Both male and female, Age between 18 to 45 years old.
•Healthy as determined by pre study medical history, physical examination, vital signs and 12-lead ECG
•at screening.
•Clinical laboratory test results that are not clinically significant and are acceptable to the investigator at
•Body mass index (BMI) between 18.5 and 29.9 kg/m2, inclusive
•Male subjects willing to comply with the contraception restrictions for this study.
•Female subjects must have a negative pregnancy test at screening, must not be lactating.
•Willing and able to comply with the requirements of the study
•Cooperative and understanding skills.
•Agreement to written informed consent form.

•- Hypersensitivity to any of the drugs components or other drug from same class.
•- Clinically significant allergic conditions.
•- Tuberculosis, invasive systemic fungal infections, other severe opportunistic infections, recent serious
•infection, recent or recurrent herpes zoster infection, chronic or recurrent infections
•- Recent or planned other investigational trial participation
•- Alcohol abuse or drug abuse including history of such addiction and not ready to abstain from the same
•till end of study.

发起方

RusBiopharm LLC Russia