CTRI/2025/04/085328 [Registered on: 22/04/2025] Trial Registered Prospectively
Last Modified On:
16/04/2025
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Randomized, Parallel Group Trial
Public Title of Study
This is a study to comparing pharmacokinetics of Pertuzumab (420 mg solution for Infusion) of Intas Pharmaceuticals Limited, India with Perjeta® of Genentech Inc, A member of Roche Group, USA and Perjeta of Roche Pharma AG, Germany in normal, healthy, adult, human male subjects.
Scientific Title of Study
A randomized, double-blind, three-arm, balanced, single-dose, parallel-group study comparing pharmacokinetics of Pertuzumab (420 mg solution for Infusion) of Intas Pharmaceuticals Limited, India with Perjeta® of Genentech Inc, A member of Roche Group, USA and Perjeta of Roche Pharma AG, Germany in normal, healthy, adult, human male subjects
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
Protocol No: 0141-24, Version No: 1.0, Dated: 10 May 2024
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Shrikrishna Kolte
Designation
General Manager
Affiliation
Lambda Therapeutic Research Ltd
Address
Lambda House, Plot No. 38, Survey no. 388, Near Silver Oak Club, S.G. Highway, Gota, Gujarat, India.
Ahmadabad GUJARAT 382481 India
Phone
07940202260
Fax
07940202021
Email
shrikrishnaskolte@lambda-cro.com
Details of Contact Person Scientific Query
Name
Dr Jogesh Mahajan
Designation
Senior Vice President
Affiliation
Lambda Therapeutic Research Ltd
Address
Lambda House, Plot No. 38, Survey no. 388, Near Silver Oak Club, S.G. Highway, Gota, Gujarat, India.
Ahmadabad GUJARAT 382481 India
Phone
07940202288
Fax
07940202021
Email
jogeshmahajan@lambda-cro.com
Details of Contact Person Public Query
Name
Dr Jogesh Mahajan
Designation
Senior Vice President
Affiliation
Lambda Therapeutic Research Ltd
Address
Lambda House, Plot No. 38, Survey no. 388, Near Silver Oak Club, S.G. Highway, Gota, Gujarat, India.
Ahmadabad GUJARAT 382481 India
Phone
07940202288
Fax
07940202021
Email
jogeshmahajan@lambda-cro.com
Source of Monetary or Material Support
Intas Pharmaceuticals Ltd,
Plot no 423/P/A, Sarkhej-Bavla highway, Village: Moraiya, Taluka: Sanand, Ahmedabad 382213, Gujarat, India
Primary Sponsor
Name
Intas Pharmaceuticals Ltd
Address
Plot no 423/P/A, Sarkhej-Bavla highway, Village: Moraiya, Taluka: Sanand, Ahmedabad 382213, Gujarat, India
Type of Sponsor
Pharmaceutical industry-Indian
Details of Secondary Sponsor
Name
Address
Intas Pharmaceuticals Ltd
Corporate House, Near Sola Bridge S.G. Highway,
Thaltej Ahmedabad (India) – 380054
Countries of Recruitment
India
Sites of Study
No of Sites = 1
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Shrikrishna Kolte
Lambda Therapeutic Research Limited
Lambda House, Plot No. 38, Survey No. 388, Near Silver Oak Club, S.G. Highway, Gota, Ahmedabad- 382481, Gujarat, India Ahmadabad GUJARAT
07940202260
shrikrishnaskolte@lambda-cro.com
Details of Ethics Committee
No of Ethics Committees= 1
Name of Committee
Approval Status
Riddhi Medical nursing Home IEC, Dr Shrikrishna Kolte
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
Comparator Agent
Perjeta 420 mg intravenous infusion (R2)
Dose: 420 mg (single dose) intravenous infusion, Pharmaceutical form: Solution for intravenous infusion, Route of administration: intravenous infusion
Dose: 420 mg (single dose) intravenous infusion, Pharmaceutical form: Solution for intravenous infusion, Route of administration: intravenous infusion
Intervention
Pertuzumab biosimilar 420mg
Dose: 420 mg (single dose) intravenous infusion, Pharmaceutical form: Solution for intravenous infusion, Route of administration: intravenous infusion
Inclusion Criteria
Age From
18.00 Year(s)
Age To
45.00 Year(s)
Gender
Male
Details
1) Non smoker, normal, healthy, adult, human male subjects greater than or equal to 18 to less than or equal to 45 years of age (both inclusive)
2) Having a body mass index (BMI) between 18.5 and 29.9 (both inclusive), kg per m2 and weighing between 60 kg and 94.9 kg (both inclusive).
3) Not having any significant disease or abnormal findings during screening, medical history, clinical examination, vital sign examination (Pulse rate, blood pressure, Respiratory rate and body temperature), laboratory evaluations, 12- lead ECG, cardiac markers (N-terminal pro-brain natriuretic peptide, troponin I), left ventricular ejection fraction (LVEF) greater than 55 percentage by echocardiogram, TMT, Echocardiogram and X-ray chest (P A view; within the last 6 months) recordings.
4) Has the willingness to adhere to the protocol requirements.
5) Able to understand and comply with the study procedures, as per the opinion of the Principal Investigator.
6) Able to give voluntary written informed consent for participation in the trial.
7) Agree to provide a written assurance to use barrier method (condoms) during the study and even after discontinuation of study till 5 months after the dose of the study
8) Agree to assure that he will not donate semen for 5 months, after participation in the study.
ExclusionCriteria
Details
1) Known hypersensitivity or idiosyncratic reaction to Pertuzumab or its constituents.
2) History or presence of any disease or disorder known to compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system.
3) Significant illness including infection within 4 weeks prior to initial dosing.
4) Any clinically significant laboratory finding at the time of screening including
a) ANC (absolute neutrophil count) less than 2000 per mm3
b) Platelet less than 150,000 per mm3
c) Hemoglobin level less than 11.1 g per dL
d) Liver function test [alanine aminotransferase and aspartate aminotransferase (ALT and AST) greater than or equal to 1.5 into upper limit normal (ULN) and alkaline phosphatase greater than or equal to 1.5 into ULN, total bilirubin greater than 1.5 mg per dL]
e) Renal function test [blood urea nitrogen greater than or equal to 1.5 into institutional normal and creatinine greater than ULN]
5) Any history or presence of asthma (including aspirin-induced asthma) or nasal polyp or NSAID-induced urticaria.
6) Previously received any monoclonal antibody or fusion protein within 6 months prior to receiving the dose of the study medicine
7) Smokers, or who have smoked, or use of tobacco or tobacco-containing products (gutkha, pan or pan masala others) within last six months prior to start of the study.
8) Ingestion or use of a medicine (prescribed and over the counter (OTC) medication including herbal remedies) at any time within 1 month prior to dosing, use of COVID-19 vaccine from 14 days prior to dosing. In any such case subject selection will be at the discretion of the Principal Investigator.
9) Subject with history of hypertension or systolic BP of greater than 140 mmHg and diastolic BP of greater than 90 mmHg at the time of screening.
10) A recent history of harmful use of alcohol (less than 2 years), ie., alcohol consumption of more than 7 standard drinks per week (A standard drink is defined as 360 mL of beer or 150 mL of wine or 45 mL of 40 percentage distilled spirits, such as rum, whisky, brandy, etc.) or consumption of alcohol or alcoholic products within 72 hours prior to receiving the study drug.
11) Use of any recreational drugs or history of drug addiction or testing positive in pre-study drug scans.
12) Donation of blood (1 unit or 350 mL) or receipt of an investigational drug or product or participation in a drug research study within 6 months prior to receiving the dose of the study medicine.
13) Positive result for human immunodeficiency virus (HIV 1 and or 2) and/or hepatitis screen including HBsAg, Anti HbcIgM and HCV antibodies tests.
14) History or presence of seizure or psychiatric disorders
15) History of cancer including lymphoma, leukaemia and skin cancer.
16) History of surgery or major trauma within 12 weeks prior to receiving study drug or surgery planned during the study
17) History of congestive heart failure
18) An unusual diet, for whatever reason (e.g. low-sodium), for 4 weeks prior to receiving the study medicine. In any such case, subject selection will be at the discretion of the Principal Investigator.
19) Consumption of grape fruit or grape fruit products within 72 hours prior to receiving study drug.
20) A history of difficulty with donating blood.
21) History of participation in a clinical study of a monoclonal antibody within 6 months prior to receiving the dose of the study medicine
22) Received live vaccine(s) within 30 days prior to dosing.
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Double Blind Double Dummy
Primary Outcome
Outcome
TimePoints
To prove the bioequivalence of Pertuzumab biosimilar ( 420 mg)
(Test) with that of US-licensed Perjeta® and EU-licensed Perjeta
To compare safety, tolerability and immunogenicity of
Pertuzumab biosimilar (Test) with that of US-licensed Perjeta®
and EU-licensed Perjeta
pre-dose sample and on day 08, 29, 57 and 99 with respect to dosing
Target Sample Size
Total Sample Size="135" Sample Size from India="135" 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
Phase 1
Date of First Enrollment (India)
27/04/2025
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="6" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Not Yet Recruiting
Publication Details
N/A
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
Primary Objective is to prove the bioequivalence of Pertuzumab biosimilar ( 420 mg) (Test) with that of US-licensed Perjeta® and EU-licensed Perjeta and secondary Objective is to compare safety, tolerability and immunogenicity of Pertuzumab biosimilar (Test) with that of US-licensed Perjeta and EU-licensed Perjeta.