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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

NCT05738993 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2023-02-22

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Biocad

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-08-08
Primary Completion
2023-04-30
Completion
2024-01-31

Countries

  • Russia

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT05738993 on ClinicalTrials.gov