NCT06886659

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Incepta Pharmaceuticals Ltd · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Breast Cancer
• Breast Neoplasms
• Breast Disease
• Antineoplastic Agents

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-01-23
• Primary completion: 2024-12-28
• Completion: 2024-12-28
• First posted: 2025-03-20
• Last updated: 2025-07-22

Locations

2 sites across 1 country: Bangladesh