Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06715540 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

StatusRecruiting
PhasePhase 1
SponsorBiocad
Started2024-03-29
View on ClinicalTrials.gov ↗
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.

Amendment history

2024-12-10
Study Identification, Study Status, Oversight, Study Description, Study Design, Contacts/Locations v1
Study descriptionrevised
[...] possibility of switching to the Stage 2 of the study (dose extensionexpansion). DLT events will be monitored for 7 days after BCD-261 inj [...]
Study sitescontacts updated at 1 of 1 site
Study title-24 characters
Safety, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of Single Ascending and Extension Doses of BCD-261 in Healthy Subjects
2024-11-28
Original filing
Biocad
26 trials monitored
See all monitored trials
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).
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