NCT05738993

A Double-Blind, Comparative, Randomized Clinical Study of the Pharmacokinetics, Safety, and Immunogenicity of a Single Intravenous Infusion of BCD-178 or Perjeta® in Healthy Volunteers

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Biocad · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is a double-blind, comparative, randomized phase I study comparing pharmacokinetics, safety and immunogenicity profiles of a biosimilar pertuzumab (BCD-178) and Perjeta after a single intravenous infusion in healthy male volunteers

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	BCD-178	A single intravenous (IV) infusion at a dose of 420 mg
DRUG	Perjeta	A single intravenous (IV) infusion at a dose of 420 mg

Timeline

• Start date: 2022-08-08
• Primary completion: 2023-04-30
• Completion: 2024-01-31
• First posted: 2023-02-22
• Last updated: 2023-02-22

Locations

2 sites across 1 country: Russia