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Study, Evaluating Pharmacokinetics, Immunogenicity and Safety Profiles of Pertuzumab Compared to Perjeta® in Healthy Man | Clinical Trials | Clareo Health

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

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

NCT05825781•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®.

Detailed Description

Pertuzumab is a recombinant humanized monoclonal antibody currently being developed by Mabscale LLC, as a proposed biosimilar to Perjeta®, which is approved as treatment in patients with metastatic breast cancer in combination with trastuzumab and docetaxel and in patients with non-metastatic breast cancer in combination with trastuzumab and chemotherapy. This randomized equivalence study is designed to meet the regulatory requirement for approval of a biosimilar product.

Eligibility

Age

18 - 45 years

Sex

MALE

Healthy Volunteers

Yes

Inclusion Criteria

•Healthy Volunteers, Men, 18 to 45 years old.
•Body mass index 18,5 - 30,0 kg/m2.
•Availability of written informed consent of the volunteer to participate in the study in accordance with applicable law.
•Volunteers should behave adequately, coherent speech should be observed.
•Volunteer consent to use an adequate method of contraception (barrier methods of contraception in combination with one of the following: non-hormonal intrauterine device; condom with intravaginal spermicide; cervical caps with spermicide; diaphragm with spermicide in the sexual partner) during the entire period of participation in the study and at least 6 months after the use of the study drug/comparator drug.
•The verified diagnosis is "healthy": the absence of pathology from the gastrointestinal tract, liver, kidneys, cardiovascular and bronchopulmonary systems, central nervous system (preliminary standard clinical, laboratory and instrumental studies did not reveal the presence of any diseases).
•Negative blood tests for HIV, syphilis and hepatitis (HBsAg and anti-HCV).
•LVEF ≥ 60% according to ECHO-CG.
•Negative urine test for drug and drug abuse.
•Negative breath alcohol test.

Exclusion Criteria

•1. Aggravated allergic anamnesis.
•2. Hypersensitivity to pertuzumab and / or other substances that are part of the study drug.
•3. Any vaccination up to 30 days before the expected date of administration of the drug according to medical history.
•4. Drug intolerance.
•5. Known intolerance to monoclonal antibody drugs (mouse, chimeric, humanized, human) according to medical history.
•6. The results of laboratory analyzes provided for by the protocol are outside the established normative indicators of the investigator site.
•7. Oncological diseases according to medical history.
•8. Acute and chronic diseases of the cardiovascular, bronchopulmonary, neuroendocrine systems, as well as diseases of the gastrointestinal tract, liver, kidneys, hematopoietic, immune systems, mental illness.
•9. More than 4 episodes of respiratory infections in the last 6 months prior to screening.
•10. Surgical interventions on the gastrointestinal tract (with the exception of appendectomy).
+15 more criteria

Locations (1)

Central Clinical Hospital "RZD-Medicina"

Moscow, Russia

Key Dates

Start Date

July 20, 2023

Primary Completion Date

January 22, 2024

Completion Date

September 1, 2024

Last Updated

August 16, 2024

Enrollment

114

ACTUAL participants

Conditions

Healthy Men

Interventions

Pertuzumab

DRUG

Perjeta®

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 16, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Single Dose, Dose-Ranging Study of 11-β Methyl Nortestosterone Dodecylcarbonate (11β-MNTDC) in Healthy Men

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