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

• Status: Recruiting
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: Male

Summary

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.

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

Details

• Lead Sponsor: EirGenix, Inc.
• Collaborator: Sacura GmbH
• Treatments: Pertuzumab

Criteria

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.