CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 94 enrolled
Drug / intervention
Adalimumab (BCD-057) +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02395055
NCT02395055Phase 1Completed
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Single Center Comparative Double Blind Randomized Clinical Study of Pharmacokinetics, Tolerance and Safety of Single Subcutaneous Injection of BCD-057 (JSC "BIOCAD", Russia) and Humira in Healthy Volunteers

Biocad·interventional·Posted Mar 20, 2015·Updated Nov 5, 2021

In Brief

A Phase 1 clinical trial evaluating Adalimumab (BCD-057) and Adalimumab (Humira) for Healthy. Completed, enrolled 94 participants across 1 site.

Detailed Summary

This clinical study is a phase 1 study which carried out to establish the pharmacokinetic equivalence and equal safety and tolerability profile of BCD-057 (adalimumab biosimilar candidate manufactured by CJSC BIOCAD, Russia) and Humira when used as a single subcutaneous injection in healthy volunteers.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesRussia
Collaborators--

Timeline

Phase 1CompletedFinished
201520162017201820192020202120222023202420252026
First PostedMar 20, 2015
Enrollment StartJun 1, 2015
Primary CompletionOct 1, 2015
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 11.3 years ago

Interventions

Adalimumab (BCD-057)drug

Adalimumab is a monoclonal antibody against tumor necrosis factor alpha

Adalimumab (Humira)drug

Adalimumab is a monoclonal antibody against tumor necrosis factor alpha