Safety, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of Ascending Doses BCD-261 in Healthy Subjects
ConditionHealthy
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18-45
SponsorBiocad
About this trial
The goal of this clinical trial is to investigate the safety, tolerability, pharmacodynamics, pharmacokinetics, and immunogenicity of BCD-261 after single subcutaneous injection at ascending doses and proposed therapeutic doses to healthy male subjects aged from 18 to 45 years old.
The study consists of the first stage (dose escalation) and the second stage (dose expansion).
Eligibility criteria
Qualifiers
Signed informed consent to participate in the study.
For cohorts 1-8: Male subjects aged 18 to 45 years at the time of signing the ICF. For cohorts 9-10: Asian male subjects aged 18 to 45 years inclusive at the time of signing the ICF.
The ability of the subject to follow the Protocol procedures, in the Investigator's opinion.
A diagnosis of "healthy", established according to standard clinical, laboratory, and instrumental methods of examination carried out at screening, according to the assessment of the Investigator, as well as historical data (absence of acute and chronic diseases of the respiratory, cardiovascular, nervous systems, gastrointestinal tract, impaired liver or kidney function).
Disqualifiers
Any medical or social condition that, in the opinion of the Investigator, prevents participation in this study.
Any confirmed or suspected immunosuppressive or immunodeficiency condition.
Any acute infectious and non-infectious diseases, including the period of convalescence, within 4 weeks from the moment of clinical recovery to signing the ICF, as well as during screening.
Diagnosis of infectious mononucleosis (documented or reported by the subject) within 2 months before signing the ICF and during screening.
Trial design
Treatments tested in this trial
- BCD-261, dose 1
- BCD-261, dose 2
- BCD-261, dose 3
- BCD-261, dose 4
- BCD-261, dose 5
- BCD-261, dose 6
- BCD-261, pre-specified therapeautic dose X
- BCD-261, pre-specified therapeautic dose X
- BCD-261, pre-specified therapeautic dose Y
Treatment groups
48 Participants
are divided into 10 treatment groups10
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Source ClinicalTrials.gov