Actively Recruiting
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
Led by Biocad · Updated on 2025-10-03
444
Participants Needed
4
Research Sites
33 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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 blood pressure (SBP 100-130 mmHg, DBP 60-90 mmHg) and pulse rate (60-90 bpm)
- Normal ECG for age without ischemia, arrhythmia, or conduction disorders
- No chronic infections (HIV, hepatitis B or C) and no history of chronic inflammatory diseases
- No signs of active or latent tuberculosis
- No acute infections within 4 weeks prior to randomization
- Ability to follow study procedures
- No history of alcoholism or drug addiction; negative tests for alcohol and drugs at screening
- Willingness to use condoms during sexual intercourse during study and for 5 months after, unless surgically sterilized
- Willingness to avoid sperm donation and conception during study and for 5 months after
- Willingness to avoid alcohol 24 hours before and after drug administration and scheduled visits
- Willingness to abstain from smoking 2 hours before drug administration and measurements
- Willingness to avoid live attenuated vaccines during the study
- Willingness to avoid medications except those prescribed for adverse events during study
You will not qualify if you...
- Mental illness or conditions affecting ability to comply with the study
- Significant surgery within 30 days before screening
- History of severe allergic reactions or allergies to monoclonal antibodies
- Inability to install venous catheter for blood collection
- Past use of adalimumab or other TNF alpha inhibitors
- Use of any medications including vitamins or supplements within 14 days before randomization
- Use of drugs affecting hemodynamics or liver function within 30 days before randomization
- Use of immune-affecting drugs 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 tests for HIV, hepatitis B or C
- Laboratory test results outside normal ranges
- Chronic diseases of cardiovascular, lung, neuroendocrine, gastrointestinal, kidney, or blood systems
- Acute infections within 4 weeks before randomization
- Smoking more than 10 cigarettes per day
- Consumption of more than 10 alcohol units per week or history of alcoholism or drug abuse
- Blood or plasma donation of 450 mL or more within 60 days before randomization
- Participation in other clinical studies with medicinal product within 90 days before randomization
- Previous participation in this study with randomization and IP administration
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
3
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