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

NCT05974969 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 146

Last updated 2023-11-18

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

DRUG

BCD-264

a single intravenous infusion of BCD-264

DRUG

Darzalex

a single intravenous infusion of Darzalex

Sponsors & Collaborators

  • Biocad

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2023-05-17
Primary Completion
2023-08-15
Completion
2023-08-15

Countries

  • Russia

Study Locations

More Related Trials

Entities

Drugs

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 NCT05974969 on ClinicalTrials.gov