Clinical Study BCD-253-1 – An Open-Label, Non-comparative Study of the Safety, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of Single Escalating Doses of BCD-253 in Healthy Volunteers.
The BCD-253-1 clinical study will assess the safety, tolerability, pharmacodynamics, pharmacokinetics, and immunogenicity of the investigational product BCD-253 after a single intravenous administration of escalating doses in healthy male volunteers who:
Have a diagnosis of “healthy”, established in accordance with standard clinical, laboratory, and instrumental examination methods performed at screening1 (as assessed by the study doctor);
Are aged 18–45 years inclusive at the time of signing the Informed Consent Form;
Have not previously taken drugs that affect the immune system, including other monoclonal antibody preparations2 having an immunosuppressive effect;
Do not have a history of allergy;
Agree to use reliable contraception during and for 3 months after their participation in the clinical study, and to refuse to donate eggs or sperm;
Have not taken part in other clinical studies within 3 months before signing the Informed Consent form, and agree to refuse to participate in other clinical studies throughout the main study period3 (up to Day 43 inclusive).
The study doctor will inform the potential participant about other eligibility criteria and contraindications for participation in this clinical study. The potential participant should read the full information about the clinical study and consult the study doctor.
The BCD-253-1 study is ongoing in one study center in St. Petersburg.
You can ask questions about participation in the clinical study and clarify the contact information of study centers through the “Any questions?” form.
Clinical Study Authorization No. 585 of the Ministry of Health of the Russian Federation dated October 17, 2023 and information about the approved study center have been published in the State Register of Medicines.
Screening is a pre-specified period for assessing the possibility of participation of a subject in a clinical study according to the eligibility criteria, based on the results of diagnostic procedures and specialist consultations.
A monoclonal antibody is a protein created by scientists in the laboratory, which is equivalent to natural immune system antibodies and designed to bind to a specific target in the human body.
The main period of this clinical study is a pre-specified period starting from the moment of administration of the investigational product and continuing up to and including Day 43 of the clinical study.