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HealthyPhase 1NCT02395055

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

A Phase 1 study testing Adalimumab (BCD-057) and Adalimumab (Humira) in people with Healthy, run by Biocad at 1 site in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Adalimumab (BCD-057) and Adalimumab (Humira)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
94 participants
Where
1 siteRussia
Study dates
Jun 2015to Oct 2015
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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;
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  • 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)

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

1 site in 1 country.

Russia1 site

  • LLC BioEk

    Saint Petersburg

Other trials in Russia

About this study

Official title: 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.

Read the 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
Being tested
Adalimumab (BCD-057), Adalimumab (Humira)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Adalimumab (BCD-057)Drug

    Also called BCD-057, Humira, Trudexa

    Adalimumab is a monoclonal antibody against tumor necrosis factor alpha

  • Adalimumab (Humira)Drug

    Also called Trudexa

    Adalimumab is a monoclonal antibody against tumor necrosis factor alpha

Study groups in NCT02395055
Study groupRoleWhat they receive
BCD-057 groupExperimentalBCD-057 (adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on week 0.
Receives: Drug: Adalimumab (BCD-057)
Humira groupActive comparatorHumira (adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on week 0.
Receives: Drug: Adalimumab (Humira)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

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

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

Secondary outcomes (6)

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

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

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

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

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

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

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

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

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

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

  6. Elimination Rate Constant of Adalimumab After Single Subcutaneous Injection of BCD-057/Humira

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Mar 2015 (estimated)
  2. Study startJun 2015
  3. Primary completionOct 2015
  4. Study completionOct 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
94 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02395055
Sponsor's protocol ID
BCD-057-1
Status last verified
Oct 2021
First submitted
16 Mar 2015
Last updated
5 Nov 2021
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Adalimumab (BCD-057) and Adalimumab (Humira) in people with Healthy, run by Biocad at 1 site in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 May 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02395055.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2021.

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