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

NCT07181694 | Recruiting Phase 1

• 1 other identifier: BCD-057-5
• Study Type: interventional
• Target: 444
• Locations: 1 country
• Sites: 4

Brief 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. 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.

Conditions

Healthy Adult Male

Keywords

Tumor Necrosis Factor Inhibitors; Anti-Inflammatory Agents; Adalimumab; Monoclonal Antibody; Pharmacokinetics

Outcome Measures

Primary Outcomes (2)

• AUC(0-∞)

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

  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

  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)

  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

  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

  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

  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

  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

Study Arms (3)

ADA100

EXPERIMENTAL

Subjects will receive a single subcutaneous injection of BCD-057 at a dose of 40 mg/0.4 mL

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

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

Drug: Adalimumab (Humira) 100 mg/mL

Interventions

Adalimumab (BCD-057) 100 mg/mL DRUG

Single subcutaneous injection

ADA100

Adalimumab (BCD-057) 50 mg/mL DRUG

Single subcutaneous injection

ADA50

Adalimumab (Humira) 100 mg/mL DRUG

Single subcutaneous injection

HUM100

Eligibility Criteria

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

You may qualify if:

• 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).
• 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.

You may not qualify if:

• 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:
• 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.

Sponsors & Collaborators

• Biocad: lead

Study Sites (4)

I.M. Sechenov First Moscow State Medical University

Moscow, 119435, Russia

RECRUITING

LLC "X7 Clinical Research"

Saint Petersburg, 194156, Russia

RECRUITING

LLC "Research Center Eco-Safety"

Saint Petersburg, 196143, Russia

RECRUITING

LLC "X7 Clinical Research"

Saint Petersburg, 199178, Russia

RECRUITING

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

Study Officials

• Arina V Zinkina-Orikhan

  Biocad

  STUDY DIRECTOR

Central Study Contacts

Svyatoslav I Klimshin

CONTACT

+7 (812) 380 49 33; klimshin@biocad.ru

Study Design

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

Study Record Dates

• First Submitted: September 12, 2025
• First Posted: September 18, 2025
• Study Start: March 12, 2025
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: October 3, 2025

Record last verified: 2025-09

Locations

RU (4)