None listed
Conditions
Brief summary
The purpose of this study is to compare a new product (called Herceptin biosimilar) to two existing Herceptin products. Who is it for? You may be eligible for this study if you are a healthy male aged between 18 and 45 years old. Study details Participants in this study will be randomised (by chance) into three groups. All participants will have a single infusion of either the new product or one of the two existing products. The infusion will be delivered through a needle in the arm over 90 minutes or less. After the infusion, participants will provide a number of blood samples so the products can be compared. It is hoped this research will be used to improve health outcomes, by providing lower priced treatments to larger numbers of cancer patients.
Interventions
A single IV infusion dose at 6 mg/kg over less than or equal to 90 minutes will be compared for the Herceptin biosimilar (NeuCeptin), EU sourced Herceptin and US sourced Herceptin. The Herceptin biosimilar is the intervention.
Sponsors
NeuClone Pty Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
Male
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy male subjects 18 to 45 years of age, inclusive. 2. Body mass index of 17.5 to 30.5 kg/m2. 3. Total body weight >50 kg and <100 kg. 4. A left ventricular ejection fraction (LVEF) within the normal range as measured by an echocardiogram within 8 weeks of randomization and diastolic function within the normal range. 5. Subjects must provide a voluntary written informed consent to participate in the study and be capable of comprehending and complying with study requirements and procedures, able and willing to complete a subject diary, return for all scheduled follow-up visits, have expressed availability for the required study period, and access to a means of telephone contact, either residential land line or mobile. 6. Males with female partners of childbearing potential must agree to practice abstinence or double-method, defined as condom for males and highly effective method of contraception (with <1% failure rate) for female partners from Screening through 90 days after the last dose of study drug. Males must also refrain from sperm donations during this time period.
Exclusion criteria
1. A history of significant clinical disease or evidence thereof at Screening. 2. Previous exposure to trastuzumab in the past and/or administration of monoclonal antibodies or similar Fc fusion product (e.g., Enbrel®) in the past 3 6 months, or 5 half-lives, whichever is longer; or anticipation of such administration during the study period. 3. Previous history of cancer, other than adequately treated basal cell carcinoma of the skin, with confirmed clinical clearance. 4. Hypertension (>140/90 mm Hg). 5. History of significant dermatologic disease (eg, eczema, allergic dermatitis). 6. History of anaphylactic reactions. 7. Autoimmune disorders. 8. Acute illness (moderate or severe) and/or fever (oral temperature >38°C) within 14 days before randomization. 9. Use of medications including antibiotics 14 days before randomization or 5 half-lives, whichever is longer. Over-the-counter medications, such as paracetamol/ibuprofen for mild aches and pains or antihistamines for hay fever, are allowed. Medications that are deemed appropriate by the Principal Investigator as not interfering with absorption, distribution, and metabolism of the investigational product are also allowed. 10. Any confirmed or suspected immunosuppressive or immunodeficient condition based on family history, medical history, and physical examination. 11. Any screening laboratory test result outside normal parameters and deemed clinically significant by the Principal Investigator . 12. Chronic administration of immunosuppressant or other immune-modifying drugs before the administration of the study drug. For glucocorticoids (prednisolone) this will mean a dose of >0.5 mg/kg/day or equivalent. Short term administration of topical or inhaled steroids could be allowed at the Principal Investigator’s discretion if not thought to have any significant systemic immunosuppressant/immune-modifying impact. 13. Administration of vaccinations before and after dosing, especially influenza vaccine, depending on time of study enrolment. 14. Self or any first degree relative history (e.g., parent, siblings) with known disturbance of coagulation or blood disorder which would be cause for anemia or excess bleeding (eg, thalassemia, coagulation factor deficiencies, severe anemia at birth). Thalassaemia minor without prior anaemic episode is allowed. 15. History of any neurological disorder, including history of seizures; excluding migraines (i.e., migraines are acceptable). 16. Prior or current acute or chronic clinically significant pulmonary (including asthma or shortness of breath), cardiovascular (including unstable angina, heart failure, or myocardial infarction), hepatobiliary, gastrointestinal, renal, neurological, or hematological functional abnormality or major congenital defects or illness that requires medical therapy, as determined by medical history or clinical assessment before entering the study. 17. Any medical or social condition that, in the opinion of the Investigator, will interfere with the study objectives or pose a risk to the study subject or may prevent the subject from completing the study follow-up. 18. Subject is a direct descendant (child or grandchild) of a member of the Sponsor, the contract research organization, any Investigator, or study site personnel.
Outcome results
None listed