A Pharmacokinetic Study Comparing EG1206A and Perjeta (Pertzumab) in Healthy Male Volunteers

Phase 1, Double-Blind, Randomized, Parallel-Group, Single-Dose, 3-Arm, Comparative Pharmacokinetic Trial of EirGenix' Pertuzumab and Perjeta® (Pertuzumab) Sourced From US and EU Administered to Healthy Male Volunteers

This trial is a single-center, single-dose, double-blind, parallel-group, randomized, 3-arm PK trial in healthy male volunteers comparing a biosimilar pertuzumab (EG1206A) to a single intravenous (i.v.) infusion to both European Union (EU) and United States of America (US) reference products.

This trial is part of a clinical development program developing a biosimilar pertuzumab, comparing the PK, safety and tolerability and immunogenicity of pertuzumab after a single intravenous (i.v.) infusion.

It assess the bioequivalence, PK characteristics, safety and tolerability as well as the immunogenicity of a test preparation containing 420 mg pertuzumab (EG1206A EirGenix Pertuzumab) as compared to marketed reference (EU and US) after a single dose i.v. infusion over 60 minutes in fasted state.

Inclusion Criteria:

• aged 18 to 55 years
• overtly healthy as determined by medical evaluation
• Body weight of at least 50 kg and not higher than 105 kg at screening
• BMI above/equal to 18.0 and below/equal to 30.0 kg/m2 at screening
• Male
• Agrees to the following during the treatment period and until 3 months after administration:
• Be and remain abstinent from heterosexual intercourse OR agree to use a male condom and female partners of childbearing potential must use an additional highly effective contraceptive method
• Abstain from donating sperm.
• Signed informed consent
• Valid COVID-19 immunization status as per current regulations

Exclusion Criteria:

• History or evidence of any clinically relevant disease, as judged by the investigator
• Any medical disorder, condition, or history of such that would impair the participant's ability to participate or complete this trial in the opinion of the investigator
• Pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination, and effects of the IMP will not be normal
• Known or suspected hypersensitivity to the IMPs (active substances, or excipients of the preparations)
• Known severe allergies e.g., allergies to more than 3 allergens
• Relevant diseases within the last 4 weeks before IMP administration
• Febrile illness within 2 weeks before IMP administration.
• History of known or suspected malignant tumors
• Known or suspected disorder of the liver
• Use of systemic/topical medicines/substances which oppose the trial objectives, or which might influence them within 4 weeks before IMP administration
• Regular use of therapeutic or recreational drugs or supplements
• Use of any herbal products or St. John's wort from 4 weeks before IMP administration
• Prior treatment with pertuzumab
• Smoking
• History of alcohol or drug abuse
• Regular daily consumption of more than 500 mL of usual beer or the equivalent quantity of approximately 20 g of alcohol in another form
• Intake of alcohol containing food and beverages from 48 h prior to admission to the ward
• Regular daily consumption of more than 1 L of methylxanthine-containing beverages
• Excluded physical therapies that might alter the PK or safety results of the trial from 7 days before IMP administration until follow-up
• Strenuous physical exercise or sauna visit with 72 h before admission to the ward
• Donation of more than 100 mL of whole blood or plasma within 4 weeks or approximately 500 mL whole blood within 3 months before IMP administration
• Plasmapheresis within 3 months before IMP administration
• Previous or concomitant participation in another clinical trial with IMP(s)
• Clinically relevant findings in the ECG
• LVEF below 55%
• Systolic blood pressure below 100 mmHg or above 140 mmHg
• Diastolic blood pressure below 50 mmHg or above 90 mmHg
• Heart rate below 50 beats/ min or above 90 beats/min
• Clinically relevant findings in the physical examination that may affect the objectives of the trial, or the safety of the participant
• Poor venous access
• Clinically relevant deviations of the screened safety laboratory parameters
• Alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, gamma glutamyl transpeptidase, or total bilirubin above 1.2 upper limit of normal
• Thyroid disorders as evidenced by assessment of thyroid stimulating hormone (TSH) level outside the normal reference range
• Positive results for hepatitis B virus surface antigen, hepatitis C virus antibodies, human immune deficiency virus antibodies, and human immune deficiency virus antigen
• Positive urine drug test
• Positive alcohol test
• Positive cotinine test
• Any criteria which, in the opinion of the investigator, preclude participation for scientific reasons, for reasons of compliance, or for reasons of the participant's safety
• Close affiliation with the investigational site
• Vulnerable participants who are e.g., institutionalized due to regulatory or juridical order dependent on sponsor, site, or investigator or not able to consent, respectively.
• History of COVID-19 within 2 months prior to screening
• Long COVID-19 syndrome or other clinically relevant COVID-19 related symptoms or sequelae
• Positive SARS-CoV-2 viral ribonucleic acid (RNA) test at admission
• No SARS-CoV-2 vaccinations should be booked within 14 days before IMP administration and until last trial visit.