| Eligibility |
Inclusion Criteria:
1. 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.
2. Healthy as defined by:
1. 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.
2. the absence of clinically significant history of neurological, endocrinal,
cardiovascular, pulmonary, hematological, immunologic, psychiatric,
gastrointestinal, renal, hepatic, and metabolic disease.
3. a LVEF within the normal range as measured by echocardiogram (ECHO) within 4
weeks prior to randomization.
4. 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:
1. 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);
2. 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:
f the following applies will be excluded from the study:
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 >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.
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 = 150 mL of wine, 360 mL of beer, or 45 mL of 40% 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.
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:
1. prescription medication within 14 days prior to dose administration;
2. 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 2 g daily);
3. 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 < 12.8 g/dL and hematocrit < 0.37 L/L at screening.
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