Healthy Adult MalePhase 1NCT07181694
A Study of Pharmacokinetics, Safety, and Immunogenicity of BCD-057 100 mg/mL, BCD-057 50 mg/mL, and Humira 100 mg/mL in Healthy Subjects
A Phase 1 study testing Adalimumab (BCD-057) 100 mg/mL, Adalimumab (BCD-057) 50 mg/mL and Adalimumab (Humira) 100 mg/mL in people with Healthy Adult Male, run by Biocad at 4 sites in Russia.
Trial summary
The aim of this study is to establish comparability of pharmacokinetic parameters and similarity of the safety and immunogenicity profiles of single subcutaneous doses of BCD 057 100 mg/mL and BCD-057 50 mg/mL, as well as BCD-057 100 mg/mL and Humira 100 mg/mL, in healthy subjects. 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 Adult Male
- What is being tested?
- Adalimumab (BCD-057) 100 mg/mL, Adalimumab (BCD-057) 50 mg/mL and Adalimumab (Humira) 100 mg/mL
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 444 participants
- Where
- 4 sitesRussia
- Study dates
- 12 Mar 2025to 12 Feb 2026
- Phase
- Phase 1
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
- Signing the Informed Consent Form of the study.
- Men aged 18-45 years inclusive at the time of signing the Informed Consent Form.
- Body mass index (BMI) in the range of 18.5-30.0 kg/m2.
- The confirmed "healthy" status based on the conventional clinical and laboratory assessments and investigations obtained as screening.
- Hemodynamic parameters within the normal range: systolic blood pressure (SBP) in the range of 100-130 mmHg, diastolic (DBP) in the range of 60-90 mmHg, wrist pulse rate 60-90 bpm, obtained at screening.
- ECG data normal for the age (no ischemia, arrhythmia, conduction disorders).
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- No chronic infections (HIV, hepatitis B or C) and no history of chronic inflammatory diseases.
- No signs of active or latent tuberculosis according to screening X-ray and tuberculosis test results.
- No acute infections within 4 weeks prior to the date of randomization.
- The ability of the subject to follow the Protocol procedures, according to the Investigator.
- No history of alcoholism or drug addiction and negative test results for alcohol, psychotropic and narcotic substances, psychoactive drugs at screening and before the IP administration.
- Willingness of subjects to use condoms during any sexual contact by penetration with persons of any sex, including pregnant women, starting from the signing of the Informed Consent Form, during the study and for 5 months after the IP administration. This requirement does not apply to subjects who have undergone surgical sterilization (bilateral orchiectomy).
- Willingness to refuse to donate sperm and conceive a child starting from the signing of the Informed Consent Form, during the study and for 5 months after the IP administration.
- Willingness not to drink alcohol within 24 hours before and after the IP administration, within 24 hours before each scheduled visit.
- Willingness to refrain from smoking within 2 hours before the IP administration and then 2 hours before each measurement of blood pressure (BP), wrist pulse rate, respiratory rate, blood sampling, ECG.
- Willingness to refrain from vaccination with live attenuated vaccines (e.g., intranasal influenza, measles, mumps, rubella, polio, BCG, yellow fever, chickenpox, and typhoid TY21a vaccines) throughout the study.
- Willingness to refrain from taking any medications, including over-the-counter drugs, vitamins and food supplements, with the exception of drugs prescribed by the Investigator for the treatment of AEs, throughout the study.
Who cannot join
- Mental illness or other conditions that may, in the Investigator's opinion, affect the subject's ability to comply with the Study Protocol.
- Any significant, in the Investigator's opinion, surgical procedures performed less than 30 days before the screening examination and potentially affecting clinical study results.
- A history of allergic reactions (anaphylactic shock or multiple drug allergy according to the Investigator's assessment).
- Known allergy or intolerance to monoclonal antibody products (murine, chimeric, humanized, fully human) or any other components of the IP.
- Impossibility of installing a venous catheter for collecting blood samples (e.g., due to skin disorders at the venipuncture sites).
- Administration and use of the following drugs:
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- Past use of adalimumab or any other drugs that inhibit tumor necrosis factor alpha.
- Regular oral or parenteral administration of any medicinal products, including over-the-counter drugs, vitamins, and dietary supplements, less than 14 days prior to the estimated date of randomization.
- Taking medications, including over-the-counter drugs, which have a pronounced effect on hemodynamics and liver function (barbiturates, omeprazole, cimetidine, etc.), less than 30 days before the estimated date of randomization.
- Using drugs that affect the immune status (cytokines and their inducers, glucocorticoids, etc.) less than 30 days before the estimated date of randomization.
- Systemic use of antibacterial, antifungal, antiviral or antiprotozoal drugs less than 30 days before the estimated date of randomization.
- Vaccination with live attenuated vaccines within 4 weeks before the estimated date of randomization.
- Positive results of screening tests for HIV, hepatitis B and C viruses.
- Results of conventional laboratory tests or investigations out of the reference ranges accepted at the study sites.
- Chronic diseases of the cardiovascular, bronchopulmonary, neuroendocrine systems, as well as diseases of the gastrointestinal tract, kidneys, blood.
- Acute infectious diseases less than 4 weeks before the estimated date of randomization, as well as chronic and other diseases that, in the Investigator's opinion, may affect the pharmacokinetics, safety, and immunogenicity of the IP.
- Smoking more than 10 cigarettes a day.
- Consumption of more than 10 units of alcohol per week (1 unit of alcohol is equivalent to ½ L of beer, 200 mL of wine or 50 mL of spirits) or a history of alcoholism, drug addiction, or drug abuse.of blood or plasma within 60 calendar days prior to the expected date of randomization.
- Donation of ≥450 mL of blood or plasma within 60 calendar days prior to the expected date of randomization.
- Participation in any clinical studies in less than 90 calendar days before the date of randomization, if the subject received a medicinal product during the clinical study.
- Previous participation in the same study if the subject was randomized and received the IP during the study.
Trial locations and contacts
4 sites in 1 country.
Russia4 sites
I.M. Sechenov First Moscow State Medical University
Moscow, 119435
LLC "X7 Clinical Research"
Saint Petersburg, 194156
LLC "Research Center Eco-Safety"
Saint Petersburg, 196143
LLC "X7 Clinical Research"
Saint Petersburg, 199178
About this study
Official title: A Double-Blind, Comparative, Randomized Clinical Study of the Pharmacokinetics, Safety, and Immunogenicity of Single Subcutaneous Doses of BCD 057 100 mg/mL, BCD-057 50 mg/mL, and Humira 100 mg/mL in Healthy Subjects
The aim of this study is to establish comparability of pharmacokinetic parameters and similarity of the safety and immunogenicity profiles of single subcutaneous doses of BCD 057 100 mg/mL and BCD-057 50 mg/mL, as well as BCD-057 100 mg/mL and Humira 100 mg/mL, in healthy subjects. The study is conducted in a population of healthy male subjects aged 18-45 years inclusive at the time of signing the ICF, with a body mass index in the range of 18.5 to 30.0 kg/m2.
Read the detailed description
The study includes following periods:
- Screening (not more than 14 days)
- Main period (Day 1 to Day 71)
Subjects meeting the eligibility criteria will be randomized with equal probability into one of three groups:
- ADA100 group - subjects will receive a single subcutaneous injection of BCD-057 at a dose of 40 mg/0.4 mL
- ADA50 group - subjects will receive a single subcutaneous injection of BCD-057 at a dose of 40 mg/0.8 mL
- HUM100 group - subjects will receive a single subcutaneous injection of Humira at a dose of 40 mg/0.4 mL
During randomization, subjects will be stratified by the following criterion:
- Body weight (<75 kg or ≥75 kg)
- Conditions
- Healthy Adult Male
- Being tested
- Adalimumab (BCD-057) 100 mg/mL, Adalimumab (BCD-057) 50 mg/mL, Adalimumab (Humira) 100 mg/mL
- Keywords
- Tumor Necrosis Factor Inhibitors, Anti-Inflammatory Agents, Adalimumab, Monoclonal Antibody, Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adalimumab (BCD-057) 100 mg/mLDrug
Single subcutaneous injection
Adalimumab (BCD-057) 50 mg/mLDrug
Single subcutaneous injection
Adalimumab (Humira) 100 mg/mLDrug
Single subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| ADA100 | Experimental | Subjects will receive a single subcutaneous injection of BCD-057 at a dose of 40 mg/0.4 mL Receives: Drug: Adalimumab (BCD-057) 100 mg/mL |
| ADA50 | Active comparator | Subjects will receive a single subcutaneous injection of BCD-057 at a dose of 40 mg/0.8 mL Receives: Drug: Adalimumab (BCD-057) 50 mg/mL |
| HUM100 | Active comparator | Subjects will receive a single subcutaneous injection of Humira at a dose of 40 mg/0.4 mL Receives: Drug: Adalimumab (Humira) 100 mg/mL |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC(0-∞)
Area Under the Plasma Concentration-time Curve From Zero (0) to Time Infinity
Measured: Before drug administration and 1, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 336, 672, 1008, 1440, 1680 hours after drug administration
Cmax
Maximum Concentration
Measured: Before drug administration and 1, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 336, 672, 1008, 1440, 1680 hours after drug administration
Secondary outcomes (6)
AUC(0-1680)
Area Under the Plasma Concentration-time Curve From Zero (0) Hours to 1680 Hours
Measured: Before drug administration and 1, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 336, 672, 1008, 1440, 1680 hours after drug administration
Tmax
Time to Reach Maximum Concentration
Measured: Before drug administration and 1, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 336, 672, 1008, 1440, 1680 hours after drug administration
T½
Half-life Period
Measured: Before drug administration and 1, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 336, 672, 1008, 1440, 1680 hours after drug administration
Vd
Volume of Distribution
Measured: Before drug administration and 1, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 336, 672, 1008, 1440, 1680 hours after drug administration
Kel
Elimination Rate Constant
Measured: Before drug administration and 1, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 336, 672, 1008, 1440, 1680 hours after drug administration
Cl
Clearance
Measured: Before drug administration and 1, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 336, 672, 1008, 1440, 1680 hours after drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2025
- Study start12 Mar 2025
- Primary completion12 Feb 2026
- Study completion12 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult MaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 444 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biocad
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Arina V Zinkina-Orikhan, Study director, Biocad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07181694
- Sponsor's protocol ID
- BCD-057-5
- Status last verified
- Jul 2026
- First submitted
- 12 Sep 2025
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No