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

NCT06886659 | Completed Phase 1 DMC

• 1 other identifier: 2022/TR/P-I/01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Breast Cancer; Breast Neoplasms; Breast Disease; Antineoplastic Agents

Keywords

Biosimilarity; Bioequivalence; Tastuzumab; Healthy male volunteers; PK

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

Study Arms (2)

Trastuzumab (proposed Trastuzumab biosimilar)

EXPERIMENTAL

40 healthy adult male will get Trastuzumab 150 mg/vial manufactured by Incepta Pharmaceuticals Ltd.

Drug: Trastuzumab (proposed Trastuzumab biosimilar)

Herclon

ACTIVE COMPARATOR

40 healthy adult male will get Herclon 150 mg/vial manufactured by Roche.

Drug: Herclon

Interventions

Trastuzumab (proposed Trastuzumab biosimilar) DRUG

6 mg/kg single intravenous infusion of Trastuzumab of Incepta Pharmaceuticals Ltd

Also known as: Test Product

Trastuzumab (proposed Trastuzumab biosimilar)

Herclon DRUG

6 mg/kg single intravenous infusion of Trastuzumab of Roche

Also known as: Reference Product

Herclon

Eligibility Criteria

• Age: 18 Years - 55 Years
• Gender Eligibility Details: Only adult male subjects will be enrolled for the study
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Incepta Pharmaceuticals Ltd: lead
• EskeGen Ltd, Bangladesh: collaborator

Study Sites (2)

Al-Manar Hospital Ltd,

Dhaka, 1207, Bangladesh

Location

Universal Medical College

Dhaka, 1215, Bangladesh

Location

MeSH Terms

Conditions

Breast Neoplasms; Breast Diseases

Interventions

Trastuzumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Manindranath Roy

  Professor (Biochemistry) United Medical College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Subjects will be administered either the Test or Reference product, according to the randomization schedule. The test and reference product will be assigned with the randomization code A and B respectively.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants will be assigned to one of the treatment arms at the beginning of the trial and continue in that arm throughout the length of the trial. Assignment to a group will be randomized.

Study Record Dates

• First Submitted: January 12, 2025
• First Posted: March 20, 2025
• Study Start: January 23, 2024
• Primary Completion: December 28, 2024
• Study Completion: December 28, 2024
• Last Updated: July 22, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: After completion of study
• Access Criteria: Journal

Locations

BA (2)