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

• Status: Not yet recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: Male

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®.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Mabscale, LLC
• Treatments: Pertuzumab

Criteria

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.