A Pharmacokinetic Study Comparing EG1206A and Perjeta (Pertzumab) in Healthy Male Volunteers
NCT05471648
Phase
Phase 1
Recruitment status
Completed
Participants
Lead sponsor
EirGenix, Inc.
Start date
2022-05-16
Number of sites
- 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.
- Short title
- A Pharmacokinetic Study Comparing EG1206A and Perjeta (Pertzumab) in Healthy Male Volunteers
- 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
- Control arm
- Active comparator
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2023-01-24
- First posted
- 2022-07-25
- Registry last updated
- 2023-01-26
- Primary completion date
- 2023-01-24
- Start date
- 2022-05-16
- Actual participants
- Participants
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- EirGenix, Inc.
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT05471648
- ClinicalTrials.gov ID
- NCT05471648
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- Quadruple masking
- Masked roles
- Participants, Care providers, Investigators, Outcome assessors
Sources for study design
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
Cmax
Timeframe: Pre-dose to day 91, 21 timepoints
Peak plasma concentration of a pertuzumab after administration
tmax
Timeframe: Pre-dose to day 91, 21 timepoints
Time to reach peak plasma concentration of pertuzumab after administration
t1/2
Timeframe: Pre-dose to day 91, 21 timepoints
Terminal elimination half-life
Drug clearance (CL)
Timeframe: Pre-dose to day 91, 21 timepoints
Total clearance
Volume of distribution (Vd)
Timeframe: Pre-dose to day 91, 21 timepoints
The apparent volume in which pertuzumab is distributed
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
Frequency of treatment-emergent adverse events (AEs)
Timeframe: Day 1 to day 91
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
- Sex
- Male
- Age groups
- Adults
- Minimum age
- 18 Years
- Maximum age
- 55 Years
- Healthy volunteers
- Yes
- 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
- 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
- CRS Clinical Research Services Berlin GmbHBerlin, Germany
Sources for sites
Other registry identifiers
- 2021-006769-40
Sources for references
Related records
Drugs (1)
Collaborators (1)
- Sacura GmbH
Lead sponsors (1)
Conditions (2)
- Breast cancer Primary condition
- Breast neoplasm