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

PHASE1UnknownINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

August 8, 2022

Primary Completion Date

April 30, 2023

Study Completion Date

January 31, 2024

Conditions
Breast Cancer
Interventions
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

Trial Locations (2)

192177

City Polyclinic №77, Saint Petersburg

194214

X7 Clinical Research, Saint Petersburg

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Biocad

INDUSTRY

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 | Biotech Hunter | Biotech Hunter