BCD-272-1, An Open-label, Single-Arm Trial of the Safety, PK and Immunogenicity of BCD-272 with a Single Rising Dose in Healthy Volunteers.
The BCD-272-1 trial will evaluate the safety, pharmacokinetics (PK) and immunogenicity of BCD-272, an investigational drug, following a subcutaneous injection with a single rising dose in healthy Caucasian and Asian male volunteers:
Diagnosed as “healthy”, based on the conventional clinical, laboratory and imaging methods of examination, conducted during the screening1 period, according to the physician investigator’s opinion, as well as medical history.
Aged 18–45 years inclusive at the time of signing the informed consent form.
Take no medications that exert effects on the immune system within 60 days prior to administration of the investigational drug.
No allergy history.
No immunization with live vaccines for 8 weeks or any other vaccines for 4 weeks prior to signing the informed consent form, and ready to abstain from vaccination with any vaccines for the whole clinical trial.
Consent use reliable contraception, and ready to refuse sperm donation after initiation of the trial participation and until the clinical trial completion.
No other clinical trial enrollment, current, as well as within 3 months prior to signing the informed consent form, and ready to withdraw from participation in other clinical studies throughout the whole clinical trial.
To ask questions about potential participation in a clinical trial, including contact details of study centers, please use a special form at ct.biocad.ru.
The Physician Investigator will tell the potential participant about other eligibility criteria and contraindications for participation in this clinical trial, as well as about other drug products used in the trial. The potential participant should read the complete study information and consult with the Physician Investigator and/or their Attending Physician.
BCD-272-1 is conducted in the study centers of the Russian Federation, namely in St. Petersburg and Moscow.
Clinical Trial Authorization No. 44 dated January 30, 2025 of the Ministry of Health of the Russian Federation and the list of approved study centers in the territory of the Russian Federation have been published in the State Register of Medicines.
Screening is a specific time period aimed at assessing a subject’s eligibility in a clinical trial according to the inclusion/non-inclusion criteria based on the diagnostic procedures and medical specialist consultations