NCT06715540

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

An Open-Label, Non-Comparative Study of the Safety, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of Ascending Doses of BCD-261 After Single Subcutaneous Injection in Healthy Subjects

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Biocad · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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).

Detailed description

The study is conducted in 2 stages. During the Stage 1 of the study, dose escalation is performed in several cohorts to assess the effects of dose-limiting toxicity (DLT), the maximum tolerated dose of BCD-261. During the dose escalation one subject ("sentinel volunteer") will be included in cohort 1. Starting from the 2nd cohort and up to the 6th cohort, the study is planned within a classic "3+3" design. Based on the results of the analysis of the Stage 1 data, including the assessment of safety, pharmacodynamics, pharmacokinetics, immunogenicity of BCD-261, a decision will be made on the possibility of switching to the Stage 2 of the study (dose expansion). DLT events will be monitored for 7 days after BCD-261 injection (during Stage 1), and may include any of CTCAE 5.0 grade ≥3 adverse events that are at least possibly related to the study drug. During the Stage 2 an extended study of the safety, pharmacodynamics, pharmacokinetics, and immunogenicity of BCD-261 at two pre-selected proposed therapeutic doses, is carried out with the inclusion of several additional cohorts of healthy caucasians and asians.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	BCD-261, dose 1	Anti-TL1A human monoclonal antibody. Solution for Subcutaneous Injection in vials
DRUG	BCD-261, dose 2	Anti-TL1A human monoclonal antibody. Solution for Subcutaneous Injection in vials
DRUG	BCD-261, dose 3	Anti-TL1A human monoclonal antibody. Solution for Subcutaneous Injection in vials
DRUG	BCD-261, dose 4	Anti-TL1A human monoclonal antibody. Solution for Subcutaneous Injection in vials
DRUG	BCD-261, dose 5	Anti-TL1A human monoclonal antibody. Solution for Subcutaneous Injection in vials
DRUG	BCD-261, dose 6	Anti-TL1A human monoclonal antibody. Solution for Subcutaneous Injection in vials
DRUG	BCD-261, pre-specified therapeautic dose X	Anti-TL1A human monoclonal antibody. Solution for Subcutaneous Injection in vials
DRUG	BCD-261, pre-specified therapeautic dose X	Anti-TL1A human monoclonal antibody. Solution for Subcutaneous Injection in pre-filled syringes
DRUG	BCD-261, pre-specified therapeautic dose Y	Anti-TL1A human monoclonal antibody. Solution for Subcutaneous Injection in pre-filled syringes

Timeline

• Start date: 2024-03-29
• Primary completion: 2025-02-01
• Completion: 2025-12-01
• First posted: 2024-12-04
• Last updated: 2024-12-16

Locations

1 site across 1 country: Russia