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

NCT ID: NCT02395055

Last Updated: 2021-11-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 94 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2015-10-31

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.

Detailed Description

This is single center comparative double blind randomized clinical study of pharmacokinetics, tolerance and safety of single subcutaneous injection of BCD-057 (CJSC BIOCAD, Russia) and Humira in healthy volunteers. The purpose of the study is to demonstrate that BCD-057 is equivalent to Humira in terms of pharmacokinetics, tolerability and safety after single subcutaneous injection in healthy volunteers.

The study will enroll 94 healthy volunteers, who will be randomized into 2 groups (1:1 ratio): volunteers from the first group will receive BCD-057; volunteers from the second group will receive Humira. Both study and reference drug will be used at the standard dose of 40 mg.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

BCD-057 group

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

Group Type: EXPERIMENTAL

Adalimumab (BCD-057)

Intervention Type: DRUG

Adalimumab is a monoclonal antibody against tumor necrosis factor alpha

Humira group

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

Group Type: ACTIVE_COMPARATOR

Adalimumab (Humira)

Intervention Type: DRUG

Adalimumab is a monoclonal antibody against tumor necrosis factor alpha

Interventions

Adalimumab (BCD-057)

Adalimumab is a monoclonal antibody against tumor necrosis factor alpha

Intervention Type: DRUG

Adalimumab (Humira)

Adalimumab is a monoclonal antibody against tumor necrosis factor alpha

Intervention Type: DRUG

Other Intervention Names

BCD-057; Humira; Trudexa; Trudexa

Eligibility Criteria

Inclusion Criteria

• subject has provided informed consent;
• male gender;
• 18 - 45 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;
• absence of alcohol or drug addiction signs (incl. history of such addiction);
• consent not to consume alcohol within 24 hours before SC injection of BCD-057/Humira and not to use more than 10 units of alcohol per week during the study (1 alcohol unit is equal ½ l of beer (1 pint), or 200 ml of wine, or 50 ml alcohol)

Exclusion Criteria

• 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;
• any use of medicines, vitamins, biologically active additives within 30 days before signing of ICF;
• use of medicines, which may influence on immunity within 30 days before signing of ICF;
• vaccination within 4 weeks prior randomization;
• smoking of more than 10 cigarettes per day;
• use of alcohol, which exceeds 10 units per week (1 alcohol unit is equal ½ l of beer (1 pint), or 200 ml of vine, or 50 ml alcohol). History of alcohol or drug addiction;
• donation of more than 450 ml of blood or plasma within 2 months prior randomization;
• simultaneous participation in any other clinical trial, as well as former participation in other clinical trials within 3 months before this study initiation;
• previous participation in this study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Biocad

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roman Ivanov, Phd

Role: STUDY_CHAIR

CJCS BIOCAD

Locations

LLC BioEk

Saint Petersburg, , Russia

Countries

Russia

Other Identifiers

BCD-057-1

Identifier Type: -

Identifier Source: org_study_id