Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2025-12-25 @ 8:24 PM
Study NCT ID:
NCT05974969
Status:
COMPLETED
Last Update Posted:
2023-11-18
First Post:
2023-06-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Assess the PK, PD, Safety and Immunogenicity of Single IV Infusion of BCD-264 and Darzalex in Healthy Subjects
Sponsor:
Biocad
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: