None listed
Conditions
Brief summary
Herceptin® (trastuzumab) is approved for the treatment of HER2-positive cancers. CuraTeQ has developed BP02 as a trastuzumab biosimilar. This study aims to show that BP02 has a high degree of similarity to Herceptin, in terms of: - Levels of drug in the blood over time - Safety and, side effects - The development of anti-drug antibodies. Approximately 111 healthy males will be enrolled in the study. Participants will receive a single 6mg/kg mg dose of either BP02, US-licensed Herceptin, or EU-approved Herceptin. The dose will be administered as an intravenous (IV) infusion over approximately 90 minutes. Blood samples to measure study drug levels and antibodies will be collected at specific time points. Safety will be monitored, and any changes in health will be recorded. The results will be used to inform further development of BP02.
Interventions
Test Product, Dose and Route of Administration:
BP02 (trastuzumab): 6 mg/kg administered as a 90-minute intravenous infusion.
Reference Therapy, Dose and Route of Administration:
EU-sourced Herceptin (trastuzumab): 6 mg/kg administered as a 90-minute intravenous infusion.
US-sourced Herceptin (trastuzumab): 6 mg/kg administered as a 90-minute intravenous infusion.
About 111 healthy men will be enrolled in the study. The study requires a 4-night stay at participating sites, and 10 clinic v
Test Product, Dose and Route of Administration: BP02 (trastuzumab): 6 mg/kg administered as a 90-minute intravenous infusion. Reference Therapy, Dose and Route of Administration: EU-sourced Herceptin (trastuzumab): 6 mg/kg administered as a 90-minute intravenous infusion. US-sourced Herceptin (trastuzumab): 6 mg/kg administered as a 90-minute intravenous infusion. About 111 healthy men will be enrolled in the study. The study requires a 4-night stay at participating sites, and 10 clinic visits, and 2 phone check-ups. Every person in the study will receive a 6 mg/kg dose of BP02 or EU-Herceptin® or US-Herceptin®. Participants have a 1/3 chance of getting each drug. Participants will not know which drug is being administered, but their study doctor can find out in an emergency. The study will have blinded and unblinding study team, where in the unblinded study team at site would be responsible for preparing the Investigational Product (IP) infusion as per the randomization schedule. The records would be verified by the unblinded Clinical Research Associate (CRA) during on-site visits.
Sponsors
CuraTeQ Biologics Private Limited
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
Male
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Signed and dated written informed consent prior to any study-specific procedures, ability to understand, and willingness to comply with the study procedures, restrictions, and requirements as judged and confirmed by the Investigator. 2. Healthy adult male subjects, 18 to 65 years (both inclusive) of age at the time of signing informed consent. 3. Having body mass index (BMI) between 18 to 30 kg/m2 and body weight between 50 to 100 kg (all inclusive). 4. Subjects with no clinically relevant abnormalities detected during baseline history, physical examination and vital signs (blood pressure, pulse rate, body temperature, including respiratory rate) as judged by the Investigator. 5. Subjects who are considered healthy as determined by clinically acceptable findings of hematology, biochemistry, coagulation tests, urinalysis, 12-lead ECG, and echocardiogram. 6. Subjects with normal thyroid function (subjects on thyroid supplementation therapy will not be eligible) at screening. 7. Subjects must refrain from donating sperm or fathering a child during the study and until 9 months after administration of BP02, EU-Herceptin or US-Herceptin administration by agreeing to use (with their female partner) 2 acceptable contraceptives. 8. Non-smokers or casual smokers who smoke no more than 5 cigarettes (or equivalent quantity of any other nicotine containing substance) per week. Subject must abstain from smoking 48 hours prior to admission to inpatient component of treatment period.
Exclusion criteria
Subjects are excluded from the study if any of the following criteria apply: 1. Known history of hypersensitivity or allergic reactions to trastuzumab or any of its excipients. 2. History of cardiovascular, hepatic, ophthalmic, pulmonary, neurological, metabolic, hematological, gastrointestinal, endocrine, immunological, psychiatric or any other disease which in the opinion of the Investigator would make the subject inappropriate for study participation. 3. Abnormal and clinically relevant (in the opinion of the Investigator) ECG, history of angina, exertional dyspnea, orthopnea, congestive heart failure, or myocardial infarction. 4. Subjects with LVEF of < 60 % on screening echocardiogram should be excluded from the study. 5. Sites are to adhere to local and institutional guidelines for exclusion of subjects with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and suspected coronavirus disease-2019 (COVID-19) infection/testing regarding the enrollment of subjects. 6. History of any cancer, including carcinoma in situ. 7. Have a positive test result for hepatitis B surface antigen (HBsAg), hepatitis C virus, or human immunodeficiency virus (HIV) I and II at screening. 8. Use of prescription or non-prescription drugs, including herbal and dietary supplements (including St. John’s Wort, grapefruit) within 14 days or 5 half-lives (whichever is longer) prior to the first dose of study treatment, unless in the opinion of the Investigator, the medication will not interfere with the study procedures or compromise subject safety. 9. Use of hematopoietic growth factors, monoclonal antibodies, or immunoglobulins within 6 months prior to screening or 5 half-lives, whichever is longer. 10. Major surgery or major trauma within past one year of screening or anticipated need for any surgery during the study duration. 11. Difficulty in blood sampling or difficulty in accessibility of veins. 12. Prior history of or current alcohol abuse or excessive intake of alcohol as judged by the Investigator and/or a positive test result in breath alcohol done before check-in. 13. Subjects with a history of drug abuse or positive drug test at screening or admission. 14. Blood donation within 90 days prior to commencement of study and during the study. 15. Participation in an investigational antibody-based study within 6 months (from postdose follow-up) and any other investigational study within 90 days prior to dosing. 16. Participation in a study with trastuzumab or HER2 targeted antibody or any prior exposure to these drugs. 17. Subjects who, in the opinion of the Investigator, are not likely to complete the study for whatever reason. 18. Any persons who are: - an employee of the Principal Investigator, clinical center, contract research organization (CRO) or Sponsor. - a relative of an employee of the clinical center, the Investigators, CRO, or the Sponsor.
Outcome results
None listed