A Study of Pharmacokinetics, Safety, and Immunogenicity of BCD-057 100 mg/mL, BCD-057 50 mg/mL, a… (NCT07181694) | Clinical Trial Compass
CompletedPhase 1
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
Russia444 participantsStarted 2025-03-12
Plain-language 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.
Who can participate
Age range
18 Years – 45 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
AUC(0-∞)
Timeframe: 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
2
Cmax
Timeframe: 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
. 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.
Exclusion criteria
. 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.