Safety, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of Ascending Doses BCD-261 in Healthy Subjects
NCT06715540 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48
Last updated 2024-12-16
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).
Conditions
- Healthy
Interventions
- 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
Sponsors & Collaborators
-
Biocad
lead INDUSTRY
Principal Investigators
-
Arina V Zinkina-Orikhan, PhD · Director of Clinical Development Department, BIOCAD
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- OTHER
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 45 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-03-29
- Primary Completion
- 2025-02-28
- Completion
- 2025-12-31
Countries
- Russia
Study Locations
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