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 sites100 target enrollmentTBD

Overview

No summary available.

Registry

who.int

Start Date

TBD

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional

Sponsor

RusBiopharm LLC Russia

•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.

Not specified