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

NCT05407779 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2024-01-31

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

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

Sponsors & Collaborators

  • Biocad

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-01-22
Primary Completion
2023-09-30
Completion
2023-09-30

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05407779 on ClinicalTrials.gov