NCT05407779

Study of the Pharmacodynamics, Pharmacokinetics, Safety, and Immunogenicity of Single Escalating Doses of BCD-180 in Healthy Volunteers

An Open-Label, Non-controlled Study of the Pharmacodynamics, Pharmacokinetics, Safety, and Immunogenicity of Single Escalating Doses of BCD-180 (JSC BIOCAD, Russia) in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Biocad · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The aim of the study is to investigate the pharmacodynamics, pharmacokinetics, safety, and immunogenicity of BCD-180 after a single intravenous administration in escalating doses to healthy volunteers.

Detailed description

The study will be carried out in 2 stages. Stage 1 involves administration of escalating doses of study drug (BCD-180) in 7 cohorts of healthy subjects. The first cohort will include one subject ("sentinel volunteer"). Each of the subsequent cohorts will include 3 subjects, each of whom will receive a preset cohort dose of BCD-180 as a single intravenous infusion. Stage 2: additionally two cohorts of healthy Asian volunteers (Cohorts 8 and 9) will be included: subjects will receive a single infusion of BCD-180 at selected doses (planned for further clinical development) based on the results of the main period of Stage 1.

Conditions

• Healthy

Interventions

Type	Name	Description
BIOLOGICAL	BCD-180, dose 1	anti-TRBV9 monoclonal antibody single infusion at dose 1
BIOLOGICAL	BCD-180, dose 2	anti-TRBV9 monoclonal antibody, single infusion at dose 2
BIOLOGICAL	BCD-180, dose 3	anti-TRBV9 monoclonal antibody, single infusion at dose 3
BIOLOGICAL	BCD-180, dose 4	anti-TRBV9 monoclonal antibody, single infusion at dose 4
BIOLOGICAL	BCD-180, dose 5	anti-TRBV9 monoclonal antibody, single infusion at dose 5
BIOLOGICAL	BCD-180, dose 6	anti-TRBV9 monoclonal antibody, single infusion at dose 6
BIOLOGICAL	BCD-180, dose 7	anti-TRBV9 monoclonal antibody, single infusion at dose 7

Timeline

• Start date: 2021-01-22
• Primary completion: 2023-09-30
• Completion: 2023-09-30
• First posted: 2022-06-07
• Last updated: 2024-01-31

Locations

1 site across 1 country: Russia