Double Blind, Randomized, Parallel-group, Single-dose, Comparative Pharmacokinetic, Safety, Tolerability Study of Exemptia injection, solution for subcutaneous use with Humira® (Adalimumab) injection.

Not Applicable

Completed

• Registration Number: CTRI/2016/05/006948
• Lead Sponsor: RusBiopharm LLC Russia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

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

screening.

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.

Exclusion Criteria

- 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Maximum serum concentration (Cmax) <br/ ><br>Area under the serum concentration-time curve from time zero to time of the last quantifiable <br/ ><br>concentration [AUC(0-t)] <br/ ><br>Area under the serum concentration-time curve from time zero extrapolated to infinity [AUC(0-inf)].Timepoint: 0 to 1680 hours

Secondary Outcome Measures

Name	Time	Method
Area under the serum concentration-time curve from time zero to 1680 hours [AUC(0-1680hrs)]Timepoint: 0-1680hrs