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

Sponsor
Mabscale, LLC (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05825781
Collaborator
(none)
114
Enrollment
1
Location
2
Arms
12
Anticipated Duration (Months)
9.5
Patients Per Site Per Month

Study Details

Study Description

Brief 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®.

Condition or Disease Intervention/Treatment Phase
Phase 1

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
114 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Other
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
Anticipated Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Jun 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Pertuzumab (manufactured by Mabscale, LLC)

Eligible subjects (57 healthy men) will receive once Pertuzumab 420 mg/14 ml in 250 ml 0,9 % NaCl intravenous on the Visit 2. The following visits are the visits of safety and pharmacokinetics visits.

Drug: Pertuzumab
i.v.
Active Comparator: Perjeta®

Eligible subjects (57 healthy men) will receive once Perjeta® 420 mg/14 ml in 250 ml 0,9% NaCl intravenous on the Visit 2. The following visits are the visits of safety and pharmacokinetics visits.

Drug: Perjeta®
i.v.

Outcome Measures

Primary Outcome Measures

  1. Concentration of pertuzumab in serum of subjects [Baseline up to 100 days after study drug administration]

Secondary Outcome Measures

  1. Rate of subjects with antibodies against pertuzumab in serum [Baseline up to 100 days after study drug administration]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
Male
Accepts 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:

  • The researcher decided that the volunteer should be excluded in the interests of the volunteer himself.

  • The volunteer is uncooperative or undisciplined.

  • The volunteer was included in violation of protocol rules.

  • The volunteer is receiving/needing additional treatment that may affect the pharmacokinetics and/or immunogenicity of the study drug.

  • Volunteer requires hospital treatment during the study.

  • Volunteers arrive at the research center later than the appointed time without objective reasons, which violates the requirements of the protocol.

  • Development of AEs when continuation of the volunteer's participation in the study is undesirable or impossible.

  • The volunteer has a positive alcohol breath test.

  • The volunteer has a positive urine test for drug abuse and drug use.

  • Withdrawal of informed consent.

  • Omission of two or more consecutive blood samples in the pharmacokinetic part of the study.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Central Clinical Hospital "RZD-Medicina" Moscow Russian Federation

Sponsors and Collaborators

  • Mabscale, LLC

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mabscale, LLC
ClinicalTrials.gov Identifier:
NCT05825781
Other Study ID Numbers:
  • PERT-1/12102020
First Posted:
Apr 24, 2023
Last Update Posted:
Apr 24, 2023
Last Verified:
Apr 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Pertuzumab

Study Results

No Results Posted as of Apr 24, 2023