An open-label, non-comparative safety, pharmacodynamics, pharmacokinetics and immunogenicity study of BCD-261 following single use with dose escalation in healthy volunteers.
The BCD-261-1 clinical trial will envestigate the safety, tolerability, pharmacodynamics, pharmacokinetics, and immunogenicity of the investigational product BCD-261 following single subcutaneous injections with dose escalation in healthy male volunteers who:
Have a diagnosis of “healthy” based on standard clinical, laboratory and instrumental examinations at screening1, according to the Investigator's assessment, as well as based on the medical history.
Are 18–45 years of age inclusive at the time of signing the informed consent form.
Have not been treated with drug products that have effect on the immune system, within less than 60 days prior the day of ininvestigational product dosing, and are anti- TL1A3 monoclonal antibody2 naive.
Have no burdened allergic history.
Have not been vaccinated with live vaccines within 8 weeks or with any other vaccines within 4 weeks before signing the informed consent form, and are also willing to abstain from vaccination with any vaccines throughout the whole study.
Agree to the conditions of reliable contraception, and are also willing to refuse sperm donation after the start of their participation in the clinical trial and until the end of the main study period4.
Are not participating and have not participated in other clinical trials within 3 months before signing the informed consent form, and also agree to refuse participation in other clinical trials throughout the whole study4.
The Investigator will inform the potential participant about other eligibility criteria and contraindications for participation in this clinical trial. Potential participants should review the complete trial information and consult with the Investigator.
The clinical trial of BCD-261-1 is taking place at one St. Petersburg study centers.
You can ask questions about participation in the clinical trial, including clarifying the study center contact information, using the “Do you have any questions?” form.
Clinical trial authorization by the Ministry of Health of the Russian Federation No. 703 dated December 4, 2023 and information about the approved study center are published in the State Register of Medicines.
Screening is a specific period for the assessment of the possibility of a subject's participation in the clinical trial according to the eligibility criteria based on the results of diagnostic procedures and specialists' consultations.
A monoclonal antibody is a protein created by scientists in the laboratory, similar to the immune system natural antibodies, designed to bind to a specific target in the human body.
TL1A is a TNF-like ligand 1A. TL1A is a proinflammatory cytokine that has important pathogenetic role in the development of inflammatory bowel diseases.
The main period of this clinical trial is a predefined period of participation in the trial from the time of investigational product dosing until clinical trial Day 57.