CTRI/2019/03/018218 [Registered on: 22/03/2019] Trial Registered Prospectively
Last Modified On:
20/03/2019
Post Graduate Thesis
No
Type of Trial
BA/BE
Type of Study
Biological
Study Design
Randomized, Parallel Group Trial
Public Title of Study
A comparative pharmacokinetic study of AryoGen Pharmed’s AryoTrust (Trastuzumab) and ‘HERCEPTIN’ (Trastuzumab) in healthy, adult, male subjects
Scientific Title of Study
A randomized, double-blind, parallel, single dose comparative pharmacokinetic study of AryoTrust (Trastuzumab) powder for concentrate for solution for intravenous infusion and ‘HERCEPTIN’ (Trastuzumab) powder for concentrate for solution for intravenous infusion in healthy, adult, male subjects.
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
Protocol No. : BA18659410, Version No. 00, Date: 14 Aug 2018
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Mayur Soni
Designation
Principal Investigator
Affiliation
Cliantha Research Limited
Address
Sigma-1 Corporate, B/H. Rajpath Club, Opposite Mann Party Plot, Off. S.G Highway, Bodakdev, Ahmedabad-380 054, Gujarat, India
Ahmadabad GUJARAT 380054 India
Phone
91-79-66135601
Fax
91-79-66135602
Email
msoni@cliantha.in
Details of Contact Person Scientific Query
Name
Dr Mayur Soni
Designation
Principal Investigator
Affiliation
Cliantha Research Limited
Address
Sigma-1 Corporate, B/H. Rajpath Club, Opposite Mann Party Plot, Off. S.G Highway, Bodakdev, Ahmedabad-380 054, Gujarat, India
GUJARAT 380054 India
Phone
91-79-66135601
Fax
91-79-66135602
Email
msoni@cliantha.in
Details of Contact Person Public Query
Name
Dr Mayur Soni
Designation
Principal Investigator
Affiliation
Cliantha Research Limited
Address
Sigma-1 Corporate, B/H. Rajpath Club, Opposite Mann Party Plot, Off. S.G Highway, Bodakdev, Ahmedabad-380 054, Gujarat, India
GUJARAT 380054 India
Phone
91-79-66135601
Fax
91-79-66135602
Email
msoni@cliantha.in
Source of Monetary or Material Support
M/s. AryoGen Pharmed, No 140. Corner of Tajbakhsh, St., 24th Km Tehran-Karaj, Makhsous Road, Alborz, I.R. Iran
Primary Sponsor
Name
AryoGen Pharmed
Address
No 140. Corner of Tajbakhsh, St., 24th Km Tehran-Karaj, Makhsous Road, Alborz, I.R. Iran
Type of Sponsor
Pharmaceutical industry-Global
Details of Secondary Sponsor
Name
Address
NIL
NIL
Countries of Recruitment
India
Sites of Study
No of Sites = 2
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Mayur Soni
Avron Hospital,
4, Shantiniketan Park,
Beside Anjali Emporium,
Nr. Lakhudi Cross Road,
Nr. Sardar Patel Statue,
Naranpura, Ahmedabad-380013,
Gujarat, India Ahmadabad GUJARAT
91-79-66135601 91-79-66135602 msoni@cliantha.in
Dr Mayur Soni
Cliantha Research Limited
Sigma-1 Corporate, B/H. Rajpath Club, Opposite Mann Party Plot, Off. S.G Highway, Bodakdev, Ahmedabad-380 054, Gujarat, India Ahmadabad GUJARAT
91-79-66135601 91-79-66135602 msoni@cliantha.in
Details of Ethics Committee
No of Ethics Committees= 2
Name of Committee
Approval Status
Medilink Ethics committee, Near Shyaml cross road, Ahmedabad
Approved
Medilink Ethics committee, Near Shyaml cross road, Ahmedabad
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Healthy Human Volunteers
Healthy
Intervention / Comparator Agent
Type
Name
Details
Intervention
AryoTrust (Trastuzumab) 150 mg
Single Dose(6 mg/kg) intravenous infusion, 90 minutes (±10 minutes)
Comparator Agent
HERCEPTIN’ (Trastuzumab) 150 mg
Single Dose(6 mg/kg) intravenous infusion, 90 minutes (±10 minutes)
Inclusion Criteria
Age From
18.00 Year(s)
Age To
45.00 Year(s)
Gender
Male
Details
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
ExclusionCriteria
Details
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 < 60%) and chest X-ray recording].
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 volunteer’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. John’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.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Sequentially numbered, sealed, opaque envelopes
Blinding/Masking
Participant and Investigator Blinded
Primary Outcome
Outcome
TimePoints
To compare the pharmacokinetics of AryoTrust (Trastuzumab) of AryoGen Pharmed, Iran to ‘HERCEPTIN’ (Trastuzumab) of Roche Registration GmbH after administration of single intravenous (IV) infusion in healthy, adult, male subjects.
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 Outcome
Outcome
TimePoints
To assess and compare the safety and tolerability of AryoTrust (Trastuzumab) of AryoGen Pharmed, Iran to ‘HERCEPTIN’ (Trastuzumab) of Roche Registration GmbH in healthy, adult, male subjects
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
Target Sample Size
Total Sample Size="60" Sample Size from India="60" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Phase of Trial
N/A
Date of First Enrollment (India)
01/04/2019
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="0" Months="3" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Not Yet Recruiting
Publication Details
None Yet
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Brief Summary
This is arandomized,
double-blind, parallel, single dose comparative pharmacokinetic study of
AryoTrust (Trastuzumab) powder for concentrate for solution for intravenous
infusion and ‘HERCEPTIN’ (Trastuzumab) powder for concentrate for solution for
intravenous infusion in healthy, adult, male subjects.