Clinical Trial

Safety, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of Ascending Doses BCD-261 in Healthy Subjects

Recruiting Phase 1
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Record status
This record was last updated December 16, 2024 (before its estimated February 2025 completion). Its status may not reflect the trial's current state.
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).
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-11-28.
Trial Details
NCT Number NCT06715540
Lead Sponsor Biocad
Conditions Healthy
Enrollment 48 participants
Start Date 2024-03-29
Primary Completion 2025-02 (estimated)
Study Completion 2025-12 (estimated)
Updated on ClinicalTrials.gov 2024-12-16