NCT06715540 Safety, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of Ascending Doses BCD-261 in Healthy Subjects
| NCT ID | NCT06715540 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Biocad |
| Condition | Healthy |
| Study Type | INTERVENTIONAL |
| Enrollment | 48 participants |
| Start Date | 2024-03-29 |
| Primary Completion | 2025-02 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
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
Inclusion Criteria: 1. Signed informed consent to participate in the study. 2. 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. 3. The ability of the subject to follow the Protocol procedures, in the Investigator's opinion. 4. 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). 5. Hemodynamic parameters within the normal range: systolic blood pressure (SBP) ranging 100 to 130 mmHg, diastolic (DBP) ranging 60 to 90 mmHg, pulse ranging 60 to 90 bpm at screening. 6. Willingness of the subjects and their female partners of childbearing pote