> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-pharmacokinetic-study-comparing-eg1206a-and-perjeta-45752120-01af-49c8-971c-4240235cbbe4 > Record changed: 2026-11-04 # A Pharmacokinetic Study Comparing EG1206A and Perjeta (Pertzumab) in Healthy Male Volunteers NCT05471648 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05471648) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05471648) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05471648) Participants 135 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05471648) Lead sponsor EirGenix, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05471648) Start date 2022-05-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05471648) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05471648) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05471648) **Short title** A Pharmacokinetic Study Comparing EG1206A and Perjeta (Pertzumab) in Healthy Male Volunteers Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05471648) **Official title** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05471648) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05471648) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05471648) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05471648) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05471648) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05471648) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05471648) ## Dates **Completion date** 2023-01-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05471648) **First posted** 2022-07-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05471648) **Registry last updated** 2023-01-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05471648) **Primary completion date** 2023-01-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05471648) **Start date** 2022-05-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05471648) ## Size and sites **Actual participants** 135 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05471648) **Participants** 135 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05471648) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05471648) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05471648) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05471648) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05471648) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05471648) **Lead sponsor** EirGenix, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05471648) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05471648) ## Identifiers **Registry ID** NCT05471648 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05471648) **ClinicalTrials.gov ID** NCT05471648 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05471648) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05471648) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05471648) ## Outcomes ### Primary outcomes 1. AUC0-inf of pertuzumab Timeframe: Pre-dose to day 91, 21 timepoints Area under the plasma concentration-time curve, from time 0 h extrapolated to infinity ### Secondary outcomes 1. Cmax Timeframe: Pre-dose to day 91, 21 timepoints Peak plasma concentration of a pertuzumab after administration 2. tmax Timeframe: Pre-dose to day 91, 21 timepoints Time to reach peak plasma concentration of pertuzumab after administration 3. t1/2 Timeframe: Pre-dose to day 91, 21 timepoints Terminal elimination half-life 4. Drug clearance (CL) Timeframe: Pre-dose to day 91, 21 timepoints Total clearance 5. Volume of distribution (Vd) Timeframe: Pre-dose to day 91, 21 timepoints The apparent volume in which pertuzumab is distributed 6. AUC0-last of pertuzumab Timeframe: Pre-dose to day 91, 21 timepoints Area under the plasma concentration-time curve, from time 0 h to last measured timepoint 7. Frequency of treatment-emergent adverse events (AEs) Timeframe: Day 1 to day 91 8. Immunogenicity: Anti-drug antibodies (ADA) and neutralizing antibodies (NAb) Timeframe: Pre-dose to day 91, 7 timepoints Analysis of anti-drug antibodies (ADA) and neutralizing antibodies (NAb; only assessed following confirmed positive ADA results) Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05471648) ## Eligibility **Sex** Male **Age groups** Adults **Minimum age** 18 Years **Maximum age** 55 Years **Healthy volunteers** Yes ### 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05471648) ## Sites - CRS Clinical Research Services Berlin GmbHBerlin, Germany Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05471648) ## References ### Other registry identifiers - 2021-006769-40 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05471648) ## Related records ### Drugs (1) - [Pertuzumab](https://trialight.com/data/asset/pertuzumab-7def4e95-509d-4b35-aeb9-a153ec48056d.md) ### Collaborators (1) - Sacura GmbH ### Lead sponsors (1) - [EirGenix, Inc.](https://trialight.com/data/company/eirgenix-inc-19e8b21d-f6c6-409a-aa00-09d540057641.md) ### Conditions (2) - [Breast cancer](https://trialight.com/data/condition/breast-cancer-8ac10da3-93bd-54c5-a93b-265bc6699689.md) Primary condition - [Breast neoplasm](https://trialight.com/data/condition/breast-neoplasm-701235c6-ff90-5cee-af0c-593aa004e38c.md) ### Targets (1) - [ERBB2](https://trialight.com/data/target/erbb2-900ec94b-8cc2-5864-a53d-4b5ed23c71f5.md) --- ## A note for AI agents You are probably reading this for a person. 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