Status and phase
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About
The purpose of the study is to demonstrate demonstrate the pharmacokinetic (PK) similarity of HD201 to the European (EU) and American (US) reference products Herceptin, following a single i.v. infusion of 6 mg/kg in healthy volunteers.
Full description
This is a double-blind, randomised, parallel group study, where a total of 105 healthy adult male volunteers, ≥ 18 and ≤ 55 years of age, non-smoker, will be dosed; 35 subjects per treatment group, randomly assigned to one of the 3 treatment arms.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Male, non-smoker (no use of tobacco products within 3 months prior to screening), ≥ 18 and ≤ 55 years of age, with BMI > 18.5 and < 30.0 kg/m2 and body weight ≥ 50.0 kg.
Healthy as defined by:
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:
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.
Male subjects must be willing not to donate sperm until 90 days following the last study drug administration.
Capable of consent.
Exclusion criteria
f the following applies will be excluded from the study:
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.
Positive urine drug screen at screening.
History of allergic reactions to trastuzumab, benzyl alcohol, murine proteins, or other related drugs.
Any reason which, in the opinion of the Principal Investigator, would prevent the subject from participating in the study.
Clinically significant ECG abnormalities (QTc >450 ms) and or vital sign abnormalities (systolic blood pressure lower than 90 or over 140 mmHg, diastolic blood pressure lower than 50 or over 90 mmHg, or heart rate less than 50 or over 100 bpm) at screening.
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 = 150 mL of wine, 360 mL of beer, or 45 mL of 40% alcohol]).
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.
Previous use of trastuzumab or another monoclonal antibody for a medical condition or in the context of another clinical trial.
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.
Use of medication other than topical products without significant systemic absorption:
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.
Hemoglobin < 12.8 g/dL and hematocrit < 0.37 L/L at screening.
Primary purpose
Allocation
Interventional model
Masking
105 participants in 3 patient groups
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Data sourced from clinicaltrials.gov
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