None listed
Conditions
Brief summary
The purpose of this study is to conduct preliminary studies of a new version of an existing medication (called Herceptin) in healthy males. Who is this study for? You may be eligible for this study if you are a male aged 18 to 55 and you are in good health with no existing conditions. Study details: Participants in this study will be randomised (by chance) into three groups. All participants will receive a single dose of breast cancer medication infused through a needle in the arm. over a period of 90 minutes. The medication will be the same, but each group will receive a different version – EU-licensed, US-licensed and a new version. Neither participants nor those giving the medication will know which is being administered. As part of this study, participants will provide blood samples and answer questions about their general health. It is hoped this research will provide evidence the new version of the medication is equivalent to the existing licensed versions.
Interventions
Arm 1: HD201 (trastuzumab) 150 mg powder formulated as a solution (in 0.9 percent sodium chloride solution) for intravenous infusion, to be administered as a single-dose of 6 mg/kg over a period of approximately 90 minutes.
Sponsors
Prestige BioPharma Australia Pty Ltd
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 55 Years
Healthy volunteers
Yes
Inclusion criteria
1) Male, non-smoker (no use of tobacco products within 3 months prior to screening), greater than or equal to 18 and less than or equal to 55 years of age, with BMI greater than or equal to 18.5 and less than or equal to 30.0 kg/m^2 and body weight greater than or equal to 50.0 kg. 2) Healthy as defined by: a) the absence of clinically significant illness and surgery within 4 weeks prior to dosing. Inclusion pre-dosing is at the discretion of the Principal Investigator. b) the absence of clinically significant history of neurological, endocrinal, cardiovascular, pulmonary, hematological, immunologic, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease. c) a LVEF within the normal range (greater than or equal to 60 percent) as measured by echocardiogram (ECHO) within 4 weeks prior to randomization. d) the absence of clinically significant history of anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome. 3) Male subjects who are not vasectomized for at least 6 months, and who are sexually active with non-sterile female partner [sterile female partners include post-menopausal women (absence of menses for 12 months prior to drug administration) or women who have had a tubal ligation, hysterectomy, or bilateral oophorectomy (at least 6 months prior to drug administration)] must be willing to use one of the following acceptable contraceptive method throughout the study and for 90 days after the last study drug administration: a) simultaneous use of condom, and for the female partner hormonal contraceptives (used since at least 4 weeks) or intra-uterine contraceptive device (placed since at least 4 weeks); b) simultaneous use of male condom, and for the female partner, diaphragm with intravaginally applied spermicide. 4) Male subjects, including men who have had vasectomy, with a pregnant partner must agree to use a condom throughout the study and for 90 days after the last study drug administration. 5) Male subjects must be willing not to donate sperm until 90 days following the last study drug administration. 6) Capable of consent.
Exclusion criteria
1) Any clinically significant abnormality or abnormal laboratory test results found during medical screening or positive test for hepatitis B, hepatitis C, or HIV found during medical screening. 2) Positive urine drug screen at screening. 3) History of allergic reactions to trastuzumab, benzyl alcohol, murine proteins, or other related drugs. 4) Any reason which, in the opinion of the Principal Investigator, would prevent the subject from participating in the study. 5) Clinically significant ECG abnormalities (QTc greater than 450 ms) and or vital sign abnormalities (systolic blood pressure lower than 90 or over 140 mmHg, diastolic blood pressure lower than 40 or over 90 mmHg, or heart rate less than 40 or over 100 bpm) at screening. 6) History of significant alcohol abuse within one year prior to screening or regular use of alcohol within six months prior to the screening visit (more than fourteen units of alcohol per week [1 unit equates to 150 mL of wine, 360 mL of beer, or 45 mL of 40 percent alcohol]). 7) History of significant drug abuse within one year prior to screening or use of soft drugs (such as marijuana) within 3 months prior to the screening visit or hard drugs (such as cocaine, phencyclidine [PCP], crack, opioid derivatives including heroin, and amphetamine derivatives) within 1 year prior to screening. 8) Previous use of trastuzumab or another monoclonal antibody for a medical condition or in the context of another clinical trial in the 6 months prior to screening. 9) Participation in a clinical research study involving the administration of an investigational or marketed drug or device within 30 days prior to the first dosing, administration of a biological product in the context of a clinical research study within 90 days prior to the first dosing, or concomitant participation in an investigational study involving no drug or device administration. 10) Use of medication other than topical products without significant systemic absorption: a) prescription medication within 14 days prior to dose administration; sporadic use of prescription such as benzodiazepines and codeine can be accepted at the discretion of the investigator. b) over-the-counter products including natural health products (e.g. food supplements and herbal supplements) within 7 days prior to dosing, with the exception of the occasional use of acetaminophen (paracetamol - up to 4 g daily); c) a depot injection or an implant of any drug within 3 months prior to dose administration. 11) Donation of plasma within 7 days prior to dosing. Donation or loss of blood (excluding volume drawn at screening) of 50 mL to 499 mL of blood within 30 days, or more than 499 mL within 56 days prior to the first dosing. 12) Hemoglobin less than 12.8 g/dL and hematocrit less than 0.37 L/L at screening.
Outcome results
None listed