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

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.