NCT05974969

A Study to Assess the PK, PD, Safety and Immunogenicity of Single IV Infusion of BCD-264 and Darzalex in Healthy Subjects

A Randomized, Double-Blind, Comparative Clinical Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Immunogenicity of Single Intravenous Infusion of BCD-264 and Darzalex® in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 146 (actual)
• Sponsor: Biocad · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical study is to establish the comparability of the pharmacokinetics and similarity of the safety, immunogenicity and pharmacodynamic profiles of BCD-264 and Darzalex following a single intravenous infusion in healthy subjects.

Detailed description

In this clinical study, each subject will receive a single intravenous infusion of BCD-264 or Darzalex, depending on the group the subject will be randomized to. The drugs are administered at the study site at a dose of 8 mg/kg. The subjects will be followed up and blood samples collected for pharmacokinetics, pharmacodynamics, immunogenicity and safety studies up to and including 71 study days after the administration of IP.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	BCD-264	a single intravenous infusion of BCD-264
DRUG	Darzalex	a single intravenous infusion of Darzalex

Timeline

• Start date: 2023-05-17
• Primary completion: 2023-08-15
• Completion: 2023-08-15
• First posted: 2023-08-03
• Last updated: 2023-11-18

Locations

3 sites across 1 country: Russia