A Study to Compare PK, Immunogenicity and Safety of Trastuzumab of Incepta Pharmaceuticals Ltd With Trastuzumab (Roche)

A Randomized, Double Blind, Parallel, Active Controlled Study to Compare PK, Immunogenicity and Safety of Trastuzumab of Incepta With Trastuzumab (Roche) in Healthy, Adult Subjects by Single IV Infusion Under Fasting Condition

Trastuzumab is an Ig G1 kappa, humanized monoclonal antibody which is most abundant subclass of IgG, that works against overexpress of HER2 (Human Epidermal Growth Factor Receptor Type 2). Trastuzumab is used to treat HER2-positive breast, gastroesophageal, and gastric cancers. HER2 regulate cell growth and survival, as well as adhesion, migration, differentiation and other cellular response. But when HER2 signaling is over expressed it causes uncontrolled cell growth which leads to the formation of cancerous tumor.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Breast Neoplasms; Antineoplastic Agents; Breast Disease
• Intervention / Treatment: Drug: Trastuzumab (proposed Trastuzumab biosimilar); Drug: Herclon

Detailed Description

In this study, healthy adult male volunteers will receive a single intravenous administration of Trastuzumab (Incepta) or Trastuzumab (Roche) according to randomization. During the course of the study, the pharmacokinetics will be assessed by sampling the levels of the drug in the blood and by comparing these levels among the different administration arms. Safety and immunologic response will also be evaluated throughout the study.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 1

Contacts and Locations

Study Locations

• Bangladesh
  • Dhaka, Bangladesh, 1207
    • Al-Manar Hospital Ltd,
  • Dhaka, Bangladesh, 1215
    • Universal Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Healthy adult male participant, age 18 to 55 years old
• BMI 18.5 to 30.0 weight in kg/height in meter2; BMI value should be rounded off to one significant digit after decimal point. Volunteer having body weight at least 50 Kg.
• 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)
• Able to understand procedure, agree to participate and willing to give informed consent.
• Willing and able to comply with the study procedures, restrictions and requirements as judged and confirmed by the principal investigator
• Male subjects, if married, must agree that they and their spouse will use adequate contraception or be of non-childbearing potential.

Exclusion Criteria:

• Have significant diseases or clinically significant abnormal findings during screening [medical history, physical examination, vital signs, laboratory evaluations, ECG, Echocardiography (LVEF less than 55%)]. Any disease or condition like diabetes, psychosis or others which might compromise the haemopoietic, gastrointestinal, renal, hepatic, cardiovascular, ophthalmic, pulmonary, metabolic, endocrine, immunological, respiratory, central nervous system or any other body system.
• History of and/or current cardiac disease
• Neutrophil count less than the lower limit of normal range during screening.
• A positive hepatitis screen (includes subtypes B & C).
• Use of hematopoietic growth factors, monoclonal antibodies or immunoglobulins within last 6 months prior to the study medication administration.
• History of any cancer, including carcinoma in situ
• Volunteer with history of angina, dyspnea, orthopnea, congestive heart failure or myocardial infarction
• 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.
• History or evidence of drug abuse or of alcoholism or of moderate alcohol use.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Trastuzumab (proposed Trastuzumab biosimilar); 40 healthy adult male will get Trastuzumab 150 mg/vial manufactured by Incepta Pharmaceuticals Ltd.	Drug: Trastuzumab (proposed Trastuzumab biosimilar); 6 mg/kg single intravenous infusion of Trastuzumab of Incepta Pharmaceuticals Ltd; Other Names: Test Product
Active Comparator: Herclon; 40 healthy adult male will get Herclon 150 mg/vial manufactured by Roche.	Drug: Herclon; 6 mg/kg single intravenous infusion of Trastuzumab of Roche; Other Names: Reference Product

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax	Maximum Observed Drug Concentration In Plasma	71 days from the starting of infusion
AUC0-t	Area Under The Concentration Versus Time Curve Up To The Last Measurable Time Point	71 days from the starting of infusion
AUC0-inf	Area Under The Concentration Versus Time Curve From Time 0 To Infinity	71 days from the starting of infusion
Immunogenicity assessment: Immunogenicity will be assessed by measuring Anti-Drug Antibodies (ADA) formation.	The incidence of Anti-Drug Antibodies (ADA) formation will be measured by taking blood samples on before treatment (pre-dose) and and on day 71	71 days from the starting of infusion
Safety assessment: The number of adverse events will be evaluated and compared between the reference and test drugs groups.	No of adverse events in both reference and test product arm will be assessed and compared by monitoring the presence of any AEs or SAEs throughout the study period.	71 days from the starting of infusion

Collaborators and Investigators

• Sponsor: Incepta Pharmaceuticals Ltd
• Collaborators: EskeGen Ltd, Bangladesh
• Investigators: Principal Investigator: Manindranath Roy, Professor (Biochemistry) United Medical College

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2024
• Primary Completion (Actual): December 28, 2024
• Study Completion (Actual): December 28, 2024

Study Registration Dates

• First Submitted: January 12, 2025
• First Submitted That Met QC Criteria: March 19, 2025
• First Posted (Actual): March 20, 2025

Study Record Updates

• Last Update Posted (Actual): July 22, 2025
• Last Update Submitted That Met QC Criteria: July 20, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Bioequivalence; PK; Healthy male volunteers; Biosimilarity; Tastuzumab
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Neoplasms; Breast Diseases; Antineoplastic Agents, Immunological; Antineoplastic Agents; Trastuzumab
• Other Study ID Numbers: 2022/TR/P-I/01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: By publication in the journal
• IPD Sharing Time Frame: After completion of study
• IPD Sharing Access Criteria: Journal
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No