Actively Recruiting
A Double-Blind, Randomized Study Comparing 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 Male Adults
Led by Biocad · Updated on 2025-10-03
444
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the pharmacokinetics, safety, and immune response profiles of different single subcutaneous doses of BCD-057 (100 mg/mL and 50 mg/mL) compared with Humira (100 mg/mL) in healthy adult males aged 18 to 45 years. The study aims to determine how these doses compare in their behavior in the body and their safety in this population with a body mass index between 18.5 and 30.0 kg/m2. The study includes a screening period of up to 14 days, followed by a main period from Day 1 to Day 71. Participants are randomly assigned to one of three groups receiving a single subcutaneous injection: BCD-057 40 mg/0.4 mL, BCD-057 40 mg/0.8 mL, or Humira 40 mg/0.4 mL. Subjects are stratified by body weight to ensure balanced groups. The study is double-blind and randomized to assess comparability of these treatments. Participants will undergo multiple blood sample collections and assessments before and several times up to 1680 hours after injection to measure drug exposure and peak concentration. Safety and immune responses will also be monitored through clinical and laboratory tests, vital signs, and electrocardiograms. The trial monitors adherence to protocol requirements and tracks any adverse events throughout the approximately 10-week study period.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form
- Male aged 18 to 45 years inclusive at consent
- Body mass index between 18.5 and 30.0 kg/m2
- Confirmed healthy status by clinical and laboratory assessments
- Normal hemodynamic parameters: systolic BP 100-130 mmHg, diastolic BP 60-90 mmHg, wrist pulse 60-90 bpm
- Normal ECG for age with no ischemia, arrhythmia, or conduction disorders
- No chronic infections like HIV, hepatitis B or C
- No active or latent tuberculosis by screening tests
- No acute infections within 4 weeks before randomization
- Ability to follow study procedures
- No history of alcoholism or drug addiction; negative tests for alcohol and drugs
- Willingness to use condoms during sexual contact and to refrain from sperm donation during and for 5 months after study drug administration
- Willingness to avoid alcohol 24 hours before and after drug administration and scheduled visits
- Willingness to avoid smoking 2 hours before drug administration and related measurements
- Willingness to avoid live attenuated vaccines throughout the study
- Willingness to avoid medications except those prescribed for adverse event treatment during the study
You will not qualify if you...
- Mental illness or conditions affecting ability to comply with study protocol
- Significant surgery within 30 days before screening affecting study results
- History of allergic reactions including anaphylaxis or multiple drug allergies
- Known allergy or intolerance to monoclonal antibody products or study drug components
- Inability to place venous catheter for blood collection
- Past use of adalimumab or similar TNF-alpha inhibitors
- Use of oral or parenteral medications, vitamins, or supplements within 14 days before randomization
- Use of drugs affecting hemodynamics or liver function within 30 days before randomization
- Use of drugs affecting immune status within 30 days before randomization
- Use of systemic antibacterial, antifungal, antiviral, or antiprotozoal drugs within 30 days before randomization
- Vaccination with live attenuated vaccines within 4 weeks before randomization
- Positive screening for HIV, hepatitis B or C
- Lab test results out of reference ranges
- Chronic cardiovascular, bronchopulmonary, neuroendocrine, gastrointestinal, kidney, or blood diseases
- Acute infections within 4 weeks before randomization
- Smoking more than 10 cigarettes per day
- Alcohol consumption exceeding 10 units per week or history of substance abuse
- Blood or plasma donation of 450 mL or more within 60 days before randomization
- Participation in any clinical study with medicinal product within 90 days before randomization
- Previous participation in this study with randomization and study drug received
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 14 days
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 71 days
Participants receive a single subcutaneous injection of one of three study drugs and are monitored for pharmacokinetics, safety, and immunogenicity.
Multiple visits for assessments before drug administration and at various times up to 71 days after injection
Trial Site Locations
Total: 4 locations
1
I.M. Sechenov First Moscow State Medical University
Moscow, Russia, 119435
Actively Recruiting
2
LLC "X7 Clinical Research"
Saint Petersburg, Russia, 194156
Actively Recruiting
3
LLC "Research Center Eco-Safety"
Saint Petersburg, Russia, 196143
Actively Recruiting
4
LLC "X7 Clinical Research"
Saint Petersburg, Russia, 199178
Actively Recruiting
Research Team
S
Svyatoslav I Klimshin
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
3
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here