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Comparative Clinical Study of Pharmacokinetics, Tolerance and Safety of BCD-057 and Humira in Healthy Volunteers

NCT02395055 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2021-11-05

Study results available
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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.

Conditions

  • Healthy

Interventions

DRUG

Adalimumab (BCD-057)

Adalimumab is a monoclonal antibody against tumor necrosis factor alpha

DRUG

Adalimumab (Humira)

Adalimumab is a monoclonal antibody against tumor necrosis factor alpha

Sponsors & Collaborators

  • Biocad

    lead INDUSTRY

Principal Investigators

  • Roman Ivanov, Phd · CJCS BIOCAD

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2015-10-31
Completion
2015-10-31

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02395055 on ClinicalTrials.gov