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

NCT05825781 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2024-08-16

No results posted yet for this study

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®.

Conditions

  • Healthy Men

Interventions

DRUG

Pertuzumab

i.v.

DRUG

Perjeta®

i.v.

Sponsors & Collaborators

  • Mabscale, LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2023-07-20
Primary Completion
2024-01-22
Completion
2024-09-30

Countries

  • Russia

Study Locations

More Related Trials

Entities

Drugs

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 NCT05825781 on ClinicalTrials.gov