RecruitingPhase 1NCT06715540

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


Sponsor

Biocad

Enrollment

48 participants

Start Date

Mar 29, 2024

Study Type

INTERVENTIONAL

Conditions

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

Sex: MALEMin Age: 18 YearsMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This early-phase study is testing a new drug called BCD-261 in healthy volunteers to assess how safe it is, how the body processes it, and what effects it has at different doses. This is an early safety and dose-finding study — not a treatment trial for sick patients. **You may be eligible if...** - You are a healthy male aged 18 to 45 years - (For some cohorts) You identify as Asian - You have no chronic or acute medical conditions - Your blood pressure and heart rate are within normal ranges - You are willing to use contraception and avoid sperm donation during and after the study **You may NOT be eligible if...** - You have any respiratory, heart, nervous system, gastrointestinal, liver, or kidney conditions - You are not able to comply with study procedures - You are participating in another clinical trial - You have any relevant allergies or significant medical history Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBCD-261, dose 1

Anti-TL1A human monoclonal antibody. Solution for Subcutaneous Injection in vials

DRUGBCD-261, dose 2

Anti-TL1A human monoclonal antibody. Solution for Subcutaneous Injection in vials

DRUGBCD-261, dose 3

Anti-TL1A human monoclonal antibody. Solution for Subcutaneous Injection in vials

DRUGBCD-261, dose 4

Anti-TL1A human monoclonal antibody. Solution for Subcutaneous Injection in vials

DRUGBCD-261, dose 5

Anti-TL1A human monoclonal antibody. Solution for Subcutaneous Injection in vials

DRUGBCD-261, dose 6

Anti-TL1A human monoclonal antibody. Solution for Subcutaneous Injection in vials

DRUGBCD-261, pre-specified therapeautic dose X

Anti-TL1A human monoclonal antibody. Solution for Subcutaneous Injection in vials

DRUGBCD-261, pre-specified therapeautic dose X

Anti-TL1A human monoclonal antibody. Solution for Subcutaneous Injection in pre-filled syringes

DRUGBCD-261, pre-specified therapeautic dose Y

Anti-TL1A human monoclonal antibody. Solution for Subcutaneous Injection in pre-filled syringes


Locations(1)

"Meditsinskiy teсhnologiy Maly"

Saint Petersburg, Russia

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NCT06715540


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