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

PHASE1RecruitingINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

March 29, 2024

Primary Completion Date

February 28, 2025

Study Completion Date

December 31, 2025

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

Trial Locations (1)

197198

RECRUITING

"Meditsinskiy teсhnologiy Maly", Saint Petersburg

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Biocad

INDUSTRY

NCT06715540 - Safety, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of Ascending Doses BCD-261 in Healthy Subjects | Biotech Hunter | Biotech Hunter