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

NCT02395055 | Completed Phase 1 Results

• 1 other identifier: BCD-057-1
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Maximum Concentration of Adalimumab After Single SC Injection of BCD-057/Humira

  0, 6, 24, 48, 72, 96, 120, 144, 168, 192, 336, 672, 1008, 1440, 1680 hours post-dose

• Area Under the Plasma Concentration-time Curve From Zero (0) to Time Infinity

  0, 6, 24, 48, 72, 96, 120, 144, 168, 192, 336, 672, 1008, 1440, 1680 hours post-dose

Secondary Outcomes (6)

• Area Under the Plasma Concentration-time Curve From Zero (0) Hours to 1680 Hours of Adalimumab After Single SC Injection of BCD-057/Humira.

  0, 6, 24, 48, 72, 96, 120, 144, 168, 192, 336, 672, 1008, 1440, 1680 hours post-dose

• Time to Reach Maximum Concentration of Adalimumab After Single Subcutaneous Injection of BCD-057/Humira

  0, 6, 24, 48, 72, 96, 120, 144, 168, 192, 336, 672, 1008, 1440, 1680 hours post-dose

• Half-life Period of Adalimumab After Single Subcutaneous Injection of BCD-057/Humira

  0, 6, 24, 48, 72, 96,120, 144, 168, 192, 336, 672, 1008, 1440, 1680 hours post-dose

• Volume of Distribution of Adalimumab After Single Administration of BCD-057/Humira

  0, 6, 24, 48, 72, 96,120, 144, 168, 192, 336, 672, 1008, 1440, 1680 hours post-dose

• Clearance of Adalimumab After Single Subcutaneous Injection of BCD-057/ Humira

  0, 6, 24, 48, 72, 96, 120, 144, 168, 192, 336, 672, 1008, 1440, 1680 hours post-dose

Study Arms (2)

BCD-057 group

EXPERIMENTAL

BCD-057 (adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on week 0.

Drug: Adalimumab (BCD-057)

Humira group

ACTIVE COMPARATOR

Humira (adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on week 0.

Drug: Adalimumab (Humira)

Interventions

Adalimumab (BCD-057) DRUG

Adalimumab is a monoclonal antibody against tumor necrosis factor alpha

Also known as: BCD-057, Humira, Trudexa

BCD-057 group

Adalimumab (Humira) DRUG

Adalimumab is a monoclonal antibody against tumor necrosis factor alpha

Also known as: Trudexa

Humira group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• subject has provided informed consent;
• male gender;
• years of age inclusively;
• a body mass index (BMI) between 18,5 and 30 kg/m2;
• absence of clinically significant hepatic, renal, gastrointestinal, cardiovascular, endocrine, respiratory, immunologic, hematologic, dermatologic, or neurologic abnormality at screening or/and in anamnesis;
• parameters of complete blood count, blood biochemistry and urinalysis do not exceed reference values, which are used at Study site laboratory. Evaluation of required laboratory parameters must be performed within 14 days before randomization;
• normal hemodynamic parameters: systolic BP 100 - 139 mm Hg, diastolic BP - 60 - 90 mm Hg, heart rate - 60 - 90 b/min;
• ECG results are normal for this age group;
• absence of chronic infections (HIV, syphilis, hepatitis В or С) and chronic inflammation;
• absence of active or latent tuberculosis;
• absence of infections within 4 weeks before randomization;
• absence of mental disorders or other conditions, which may affect the ability of participant to follow Protocol;
• health well-being (by volunteer's opinion) for at least 30 days before randomization;
• ability to follow Protocol procedures;
• consent of volunteers and their sexual partners with childbearing potential to use adequate contraception during screening period and the main study part;

You may not qualify if:

• history of adalimumab use or any other TNF inhibitors;
• known severe allergy (anaphylaxis or multidrug intolerance);
• known intolerance of monoclonal antibodies or any other excipients of BCD-057/Humira;
• major surgery within 30 days before ICF signing;
• presence of clinically significant hepatic, renal, gastrointestinal, cardiovascular, endocrine, respiratory, immunologic, hematologic, dermatologic, or neurologic abnormality at screening or/and in anamnesis.
• infections which required hospitalization, parenteral anti-infectives within 6 months before randomization;
• positive results of tests for HIV-1 and HIV-2 antibodies, positive Hbs-Ag, HBc IgM, total antibodies against HCV, positive results of RPR-test;
• more than 4 episodes of acute respiratory infection within 6 months before randomization;
• any malignancy (present or history);
• tuberculosis, including latent forms;
• shingles (present or history).
• history of seizures;
• any disorders or other conditions, which may affect pharmacokinetics of BCD-057/Humira (e.g. chronic liver diseases, chronic kidney diseases, cardiovascular disorders, lung disorders, endocrine diseases, etc.).
• use of systemic antimicrobial or antifungal medicines within 2 months before randomization;
• regular oral or parenteral use of any medicines, vitamins, biologically active additives within two weeks before signing of ICF;

Sponsors & Collaborators

• Biocad: lead

Study Sites (1)

LLC BioEk

Saint Petersburg, Russia

Location

MeSH Terms

Interventions

Adalimumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Biryulin Andrey
• Organization: BIOCAD

biryulin@biocad.ru

+7812380 49 33

Study Officials

• Roman Ivanov, Phd

  CJCS BIOCAD

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2015
• First Posted: March 20, 2015
• Study Start: June 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: November 5, 2021
• Results First Posted: May 23, 2016

Record last verified: 2021-10

Locations

RU (1)