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

October 8, 2021 updated by: Biocad

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

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
94

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Drug: Adalimumab (BCD-057)
Adalimumab is a monoclonal antibody against tumor necrosis factor alpha
Other Names:
  • Humira
  • BCD-057
  • Trudexa
Active Comparator: Humira group
Humira (adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on week 0.
Drug: Adalimumab (Humira)
Adalimumab is a monoclonal antibody against tumor necrosis factor alpha
Other Names:
  • Trudexa

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Maximum Concentration of Adalimumab After Single SC Injection of BCD-057/Humira
Time Frame: 0, 6, 24, 48, 72, 96, 120, 144, 168, 192, 336, 672, 1008, 1440, 1680 hours post-dose
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
Time Frame: 0, 6, 24, 48, 72, 96, 120, 144, 168, 192, 336, 672, 1008, 1440, 1680 hours post-dose
0, 6, 24, 48, 72, 96, 120, 144, 168, 192, 336, 672, 1008, 1440, 1680 hours post-dose

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Area Under the Plasma Concentration-time Curve From Zero (0) Hours to 1680 Hours of Adalimumab After Single SC Injection of BCD-057/Humira.
Time Frame: 0, 6, 24, 48, 72, 96, 120, 144, 168, 192, 336, 672, 1008, 1440, 1680 hours post-dose
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
Time Frame: 0, 6, 24, 48, 72, 96, 120, 144, 168, 192, 336, 672, 1008, 1440, 1680 hours post-dose
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
Time Frame: 0, 6, 24, 48, 72, 96,120, 144, 168, 192, 336, 672, 1008, 1440, 1680 hours post-dose
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
Time Frame: 0, 6, 24, 48, 72, 96,120, 144, 168, 192, 336, 672, 1008, 1440, 1680 hours post-dose
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
Time Frame: 0, 6, 24, 48, 72, 96, 120, 144, 168, 192, 336, 672, 1008, 1440, 1680 hours post-dose
0, 6, 24, 48, 72, 96, 120, 144, 168, 192, 336, 672, 1008, 1440, 1680 hours post-dose
Elimination Rate Constant of Adalimumab After Single Subcutaneous Injection of BCD-057/Humira
Time Frame: 0, 6, 24, 48, 72, 96, 120, 144, 168, 192, 336, 672, 1008, 1440, 1680 hours post-dose
0, 6, 24, 48, 72, 96, 120, 144, 168, 192, 336, 672, 1008, 1440, 1680 hours post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Biocad

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Roman Ivanov, Phd, CJCS BIOCAD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 16, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 17, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 20, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 5, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 8, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BCD-057-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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