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

NCT05825781 | Active Not Recruiting Phase 1

• 1 other identifier: PERT-1/12102020
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

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®.

Conditions

Healthy Men

Outcome Measures

Primary Outcomes (1)

• Concentration of pertuzumab in serum of subjects

  Baseline up to 100 days after study drug administration

Secondary Outcomes (1)

• Rate of subjects with antibodies against pertuzumab in serum

  Baseline up to 100 days after study drug administration

Study Arms (2)

Pertuzumab (manufactured by Mabscale, LLC)

EXPERIMENTAL

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

Perjeta®

ACTIVE COMPARATOR

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®

Interventions

Pertuzumab DRUG

i.v.

Pertuzumab (manufactured by Mabscale, LLC)

Perjeta® DRUG

i.v.

Perjeta®

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Aggravated allergic anamnesis.
• Hypersensitivity to pertuzumab and / or other substances that are part of the study drug.
• Any vaccination up to 30 days before the expected date of administration of the drug according to medical history.
• Drug intolerance.
• Known intolerance to monoclonal antibody drugs (mouse, chimeric, humanized, human) according to medical history.
• The results of laboratory analyzes provided for by the protocol are outside the established normative indicators of the investigator site.
• Oncological diseases according to medical history.
• 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.
• More than 4 episodes of respiratory infections in the last 6 months prior to screening.
• Surgical interventions on the gastrointestinal tract (with the exception of appendectomy).
• Acute infectious diseases less than 4 weeks prior to study entry.
• Taking drugs that have a pronounced effect on hemodynamics, liver function, etc. (barbiturates, omeprazole, cimetidine, etc.) less than 2 months before the start of this study.
• Regular drug intake less than 2 weeks before the start of the study.
• Systolic blood pressure less than 100 mm Hg. Art. or above 130 mm Hg. Art.; diastolic blood pressure less than 60 mm Hg. Art. or above 90 mm Hg. Art.; Heart rate less than 60 bpm or more than 90 bpm; respiratory rate less than 12 and more than 20 per minute
• Donation of blood (450 ml of blood or more) less than 3 months before the start of the study.

Sponsors & Collaborators

• Mabscale, LLC: lead

Study Sites (1)

Central Clinical Hospital "RZD-Medicina"

Moscow, Russia

Location

MeSH Terms

Interventions

pertuzumab

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2023
• First Posted: April 24, 2023
• Study Start: July 20, 2023
• Primary Completion: January 22, 2024
• Study Completion: September 1, 2024
• Last Updated: August 16, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)