CTRI/2025/04/085562 [Registered on: 24/04/2025] Trial Registered Prospectively
Last Modified On:
21/04/2025
Post Graduate Thesis
No
Type of Trial
BA/BE
Type of Study
Study Design
Randomized, Parallel Group Trial
Public Title of Study
Study to compare the pharmacokinetics, safety, tolerability, immunogenicity of trastuzumab from three subcutaneous injection formulations: the test product (Zercepac 600 mg) and the reference products (EU-sourced Herceptin 600 mg and US-sourced Herceptin Hylecta 600mg) in healthy adult male subjects
Scientific Title of Study
A randomized, double-blind, single-dose, Phase I, parallel group study to
compare the pharmacokinetics, safety, tolerability, and immunogenicity of
trastuzumab from three subcutaneous (SC) injection formulations: the test
product (Zercepac 600 mg) and the reference products (EU-sourced Herceptin
600 mg and US-sourced Herceptin Hylecta 600mg) in healthy adult male
subjects
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
Protocol No: 0204-24, Version: 1.0, Date: 02 October 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
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
Ahmadabad GUJARAT 382481 India
Phone
07940202214
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
Ahmadabad GUJARAT 382481 India
Phone
07940202214
Fax
07940202021
Email
jogeshmahajan@lambda-cro.com
Source of Monetary or Material Support
Intas Pharmaceuticals Ltd, Corporate House, Nr. Sola Bridge, S.G. Highway, Thaltej,
Ahmedabad – 380054, Gujarat, India
Primary Sponsor
Name
Intas Pharmaceuticals Ltd
Address
Corporate House, Nr. Sola Bridge, S.G. Highway, Thaltej, Ahmedabad – 380054, Gujarat, India
Type of Sponsor
Pharmaceutical industry-Indian
Details of Secondary Sponsor
Name
Address
NA
NA
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 Ltd
Lambda house, Plot No. 38, Survey no.
388, Near Silver Oak Club, S. G. Highway,
Gota 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
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
EU-sourced Herceptin® 600 mg
solution for injection in via (R1)
Dose and route of administration: 600 mg per 5 mL Subcutaneous injection,
Strength: 600 mg solution for injection,
Pharmaceutical form: Solution for injection in vial,
Total Duration: single-dose, parallel group study.
Comparator Agent
US-sourced Herceptin® Hylecta
600 mg injection for subcutaneous use in vial (R2)
Dose and route of administration: 600 mg5 mL Subcutaneous injection,
Strength: 600 mg solution for injection,
Pharmaceutical form: Solution for injection in vial,
Total Duration: single-dose, parallel group study
Intervention
Zercepac 600 mg SC (T)
Dose and route of administration: 600 mg per 5 mL solution (single dose) subcutaneous injection,
Strength: 600 mg solution for injection,
Pharmaceutical form: Solution for injection in vial,
Total Duration: single-dose, parallel group study.
Inclusion Criteria
Age From
18.00 Year(s)
Age To
55.00 Year(s)
Gender
Male
Details
1) Non-smoking, healthy adult male subjects between 18 and 55 years of age (both inclusive)
2) Having a body weight between 50 kg and 94.9 kg (both inclusive) and body mass index (BMI) between 18.5 and 30.0 kg per m2 (both inclusive); calculated as weight in kg per height squared in meters (BMI equal to kg per m2). Stratification will be done based on weight to less than or equal to 70 kg and greater than 70 kg.
3) Not having any clinically significant disease or clinically significant abnormal findings (Investigator discretion) during screening based on medical history, physical examination,
vital signs measurement (pulse rate, blood pressure, respiratory rate, and body temperature), laboratory evaluations, and cardiac markers (N-terminal pro-brain natriuretic
peptide, HS Trop I), 12-lead ECG, left ventricular ejection fraction (LVEF) greater than 55 percentage by echocardiogram (2D Echo), TMT, and chest Xray (P A view; within the last 6 months).
4) Has the willingness to adhere to the protocol requirements.
5) Capable of communicating effectively with study personnel
6) Able to understand and comply with the study procedures, as per the opinion of the investigator.
7) Able to give voluntary written informed consent for participation in the trial.
8) Subjects willing to use a barrier method (condoms) of contraception during the study and
for 7 months after dosing in the study.
9) Subject should not be donating semen during the study and for 7 months after dosing.
ExclusionCriteria
Details
1) Known hypersensitivity or idiosyncratic reaction to trastuzumab 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) Clinically significant illness within four (4) weeks prior to initial dosing or symptoms or
signs suggestive of any infection
4) Any clinically significant abnormal laboratory findings at the discretion of the investigator
at the time of screening
5) Any history or presence of asthma (including aspirin-induced asthma) or nasal polyp or
NSAID-induced urticaria.
6) Donation of blood (1 unit or 350 mL) or Receipt of an investigational medicinal product or
participation in a drug research study within a period of 180 days prior to the dose of study
medication. If investigational medicinal product is received within 180 days where there is no
blood loss except safety lab testing, subject can be included considering 10 half-lives
duration of investigational medicinal product received. If involved in a drug research
study with an investigational medicinal product which is a monoclonal antibody or
fusion protein then, 12 months.
7) Smokers, or who have smoked 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, any vaccine (including COVID-
19 vaccine) from 14 days prior to receiving the IMP; live vaccine(s) within 30 days prior
to dosing). In any such case subject selection will be at the discretion of the Investigator.
9) Subject with history of untreated hypertension or systolic BP of greater than 140 mmHg and diastolic
BP of greater than 90 mmHg at the time of screening (reconfirmed at check-in).
10) A recent history of harmful use of alcohol (less than 2 years), i.e., alcohol consumption of more
than 14 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) History of drug addiction or testing positive for drugs-of-abuse at screening.
12) Positive result for human immunodeficiency virus (HIV 1 and or 2) and or hepatitis screen
including HBsAg, Anti HBc IgM and HCV antibodies tests.
13) History or presence of any psychiatric disorders
14) History of any clinically significant lung disease.
15) History of cancer including lymphoma, leukemia, 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) Presence of tattoos or scars or any type of skin lesions due to infection, burn, wound or
inflammation at the proposed site of dosing.
19) Previously received any monoclonal antibody or fusion protein for treatment purpose.
20) History of participation in a clinical study of a monoclonal antibody or fusion protein in
the past 12 months.
21) 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
investigator.
22) Consumption of citrus fruits (including grapefruit or grapefruit products) and or apple or
pineapple within 72 hours prior to receiving study drug.
23) A history of difficulty with donating blood or veins unsuitable for collection.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
On-site computer system
Blinding/Masking
Double Blind Double Dummy
Primary Outcome
Outcome
TimePoints
To compare the pharmacokinetic (PK) parameters of Zercepac
600 mg SC (T) with that of EU-sourced Herceptin® 600 mg SC (R1)
and US-sourced Herceptin® Hylecta 600mg SC (R2)
To compare the immunogenicity of Zercepac 600 mg SC (T) with
that of EU-sourced Herceptin 600 mg SC (R1) and US-sourced
Herceptin Hylecta 600 mg SC (R2).
at pre-dose (0 hours in 8.5 mL X 4 serum gel separation tubes) and 8.5 mL blood samples will be collected on Day 9, Day 18, Day 31, Day 57, Day 85, and Day 169 post-dose for immunogenicity evaluation. Samples at and after 96 hours post-dose will be collected on an ambulatory basis
To compare the safety and tolerability of Zercepac 600 mg SC (T)
with that of EU-sourced Herceptin 600 mg SC (R1) and USsourced
Herceptin Hylecta 600 mg SC (R2).
Safety: Monitoring of adverse events, laboratory parameters, vital signs, and physical examination
Target Sample Size
Total Sample Size="162" Sample Size from India="162" 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)
02/05/2025
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
This is a study to compare the pharmacokinetics, safety, tolerability, and immunogenicity of trastuzumab from three subcutaneous (SC) injection formulations: the test product (Zercepac 600 mg) and the reference
products (EU-sourced Herceptin 600 mg and US sourced Herceptin Hylecta 600mg) in healthy adult male subjects