None listed
Conditions
Interventions
Intervention1: AryoTrust (Trastuzumab) 150 mg: Single Dose(6 mg/kg) intravenous infusion, 90 minutes (±10 minutes)
Control Intervention1: HERCEPTINâ?? (Trastuzumab) 150 mg: Single Dose(6 mg/kg) intra
Sponsors
AryoGen Pharmed
Eligibility
Inclusion criteria
Inclusion criteria: 1) Age: 18 to 45 years, both inclusive 2) Gender: Male 3) BMI: 18.5 to 30.0 weight in kg/(height in meter)2 both inclusive; BMI value should be rounded off to one significant digit after decimal point (e.g. 30.04 rounds down to 30.0, while 18.45 rounds up to 18.5). 4) Volunteer having body weight at least 50 Kg. 5) Non-smokers and non-tobacco user (i.e. having no past history of smoking and tobacco consuming for at least one year prior to study) 6) Able to communicate effectively with study personnel. 7) Able to give written informed consent to participate in the study. 8) Willing and able to comply with the study procedures, restrictions and requirements as judged and confirmed by the principal or sub-investigator 9) Male subjects must agree that they and their female spouse/partners will use adequate contraception or be of non-childbearing potential. 10) All volunteers must be judged by the principal or sub-investigator or physician as normal and healthy during a pre-study safety assessment performed within 28 days of the first dose of study medication
Exclusion criteria
Exclusion criteria: 1) History of allergic responses/exposure to Trastuzumab or murine proteins or other related drugs, or antibodies. 2) Have significant diseases or clinically significant abnormal findings during screening [medical history, physical examination, vital signs, laboratory evaluations, pulmonary function test, ECG, Echocardiography (LVEF of 3) Any disease or condition like diabetes, psychosis or others which might compromise the haemopoeitic, gastrointestinal, renal, hepatic, cardiovascular, ophthalmic, pulmonary, metabolic, endocrine, immunological, respiratory, central nervous system or any other body system. 4) History or presence of bronchial asthma. 5) Use of any hormone replacement therapy within 3 months prior to the study medication administration. 6) A depot injection or implant of any drug within 3 months prior to the study medication administration. 7) Use of enzyme-modifying drugs within 30 days prior to the study medication administration. 8) History or evidence of drug dependence or of alcoholism or of moderate alcohol use. 9) History of difficulty with donating blood or difficulty in accessibility of veins. 10) A positive hepatitis screen (includes subtypes B & C). 11) A positive test result for HIV antibody and / or syphilis (RPR/VDRL). 12) Volunteers who have received a known Investigational drug within 03 months of the administered drug prior to the study medication administration or have donated blood or loss of blood 50 ml to 100 ml within 30 days or 101 ml to 200 ml within 60 days or >200 ml within 90 days (excluding volume drawn at screening for this study) prior to first dose of study medication, whichever is greater. 13) Intolerance to venipuncture 14) Any food allergy, intolerance, restriction or special diet that, in the opinion of the Principal Investigator or Sub-Investigator, could contraindicate the volunteerâ??s participation in this study. 15) Institutionalized volunteers. 16) Volunteer with history of angina, dyspnea, orthopnoea, congestive heart failure or myocardial infarction. 17) History of any cancer, including carcinoma in situ. 18) Use of prescription or non-prescription drugs, including analgesics, herbal remedies, dietary supplements (including St. Johnâ??s Wort, but with the exception of paracetamol, NSAIDs, Corticosteroids and Antihistamines or vitamins) within 14 days prior to the study medication administration, unless in the opinion of the Investigator, the medication will not interfere with the study procedures or compromise subject safety 19) Use of haematopoetic growth factors, monoclonal antibodies or immunoglobulins within last 6 months prior to the study medication administration. 20) Major surgery or major trauma within past one year of screening or anticipated need for any surgery during the study duration. 21) Participation in a study with Trastuzumab or HER 2 targeted antibody or any prior exposure to these drugs or any other monoclonal antibody drugs. 22) Neutrophil count less than the lower limit of normal range during screening. 23) Volunteers who have received live vaccine(s) within 30 days prior to screening or who will require a vaccine(s) between Screening and the End of Study visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the pharmacokinetics of AryoTrust (Trastuzumab) of AryoGen Pharmed, Iran to â??HERCEPTINâ?? (Trastuzumab) of Roche Registration GmbH after administration of single intravenous (IV) infusion in healthy, adult, male subjects.Timepoint: Pre-dose (0.0 hour) and at 0.5 (coinciding with the infusion), 1.0 (coinciding with the infusion), 1.5 (immediately before the end of infusion), 3.0, 6.0, 12.0 and 24.0,48.0, 72.0, 96.0, 168.0, 336.0, 672.0, 1008.0 and 1344.0 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess and compare the safety and tolerability of AryoTrust (Trastuzumab) of AryoGen Pharmed, Iran to â??HERCEPTINâ?? (Trastuzumab) of Roche Registration GmbH in healthy, adult, male subjectsTimepoint: Incidence of adverse events/ serious adverse events. Clinical and laboratory parameters. Vital signs: check-in, check-out, pre dose, at 0.5, 1.0, 1.5 , 3.0, 6.0, 12.0 , 48.0, 72.0, 96.0, 168.0, 336.0, 672.0, 1008.0 and 1344.0hrs after start of infusion. 12-lead ECG: Pre-dose, at 1.0, 3.0, 6.0 and 12.0 hrs after start of infusion and Check-out. Injection site assessment: Check-in and 0.5, 1.0, 1.5, 3.0, 6.0 and 12.0 hrs | — |
Countries
India
Contacts
Public ContactDr Mayur Soni
Cliantha Research Limited
Outcome results
None listed