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

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 Humira® (Adalimumab) injection, solution for subcutaneous use(40mg/0.8ml) administered to healthy subjects.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2016/05/006948
Enrollment
100
Registered
2016-05-18
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Humira® (Adalimumab) injection, solution for subcutaneous use (40 mg/0.8 ml) Dosage and Mode of administration: Injection, Single subcutaneous dose over 2-3 minutes: Humira® (Adalimum

Sponsors

RusBiopharm LLC Russia
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Maximum serum concentration (Cmax) Area under the serum concentration-time curve from time zero to time of the last quantifiable concentration [AUC(0-t)] Area under the serum concentration-time curve from time zero extrapolated to infinity [AUC(0-inf)].Timepoint: 0 to 1680 hours—

Secondary

MeasureTime frame
Area under the serum concentration-time curve from time zero to 1680 hours [AUC(0-1680hrs)]Timepoint: 0-1680hrs—

Countries

India

Contacts

Public ContactDr Rohan S

NEXUS CLINICAL RESEARCH (INDIA) LTD

pm_medaffairs@nexuscro.com91-22-27714204

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026