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ACTIVE NOT RECRUITING
NCT05825781
PHASE1

Study, Evaluating Pharmacokinetics, Immunogenicity and Safety Profiles of Pertuzumab Compared to Perjeta® in Healthy Man

Sponsor: Mabscale, LLC

View on ClinicalTrials.gov

Summary

PERT-1/12102020 is a double-blind randomized single-center clinical trial comparing pharmacokinetics, immunogenicity and safety profiles of Pertuzumab (manufactured by Mabscale, LLC) compared to Perjeta® in healthy men. The purpose of the study is to demonstrate equivalence of pharmacokinetics, immunogenicity and safety of Pertuzumab (manufactured by Mabscale, LLC) to Perjeta®.

Official title: Randomized Double Blind Comparative Clinical Study Evaluating Pharmacokinetics and Safety in Single Intravenous Use of Pertuzumab (Manufactured by Mabscale, LLC) Compared to Perjeta® in Healthy Men

Key Details

Gender

MALE

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

114

Start Date

2023-07-20

Completion Date

2024-09

Last Updated

2024-08-16

Healthy Volunteers

Yes

Conditions

Interventions

DRUG

Pertuzumab

i.v.

DRUG

Perjeta®

i.v.

Locations (1)

Central Clinical Hospital "RZD-Medicina"

Moscow, Russia