a pharmacokinetic study comparing eg1206a and perjeta (pertzumab) in healthy male volunteers

Conditions: Breast Cancer

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.

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.

Eligibility 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.

Keywords: her2 positive early stage breast cancer metastatic breast cancer combination therapy inhibiting map kinase p13k/akt