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

NCT06886659 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-07-22

No results posted yet for this study

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

Interventions

DRUG

Trastuzumab (proposed Trastuzumab biosimilar)

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

DRUG

Herclon

6 mg/kg single intravenous infusion of Trastuzumab of Roche

Sponsors & Collaborators

  • EskeGen Ltd, Bangladesh

    collaborator UNKNOWN

  • Incepta Pharmaceuticals Ltd

    lead INDUSTRY

Principal Investigators

  • Manindranath Roy · Professor (Biochemistry) United Medical College

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-01-23
Primary Completion
2024-12-28
Completion
2024-12-28

Countries

  • Bangladesh

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06886659 on ClinicalTrials.gov