NCT05765357

Clinical Study to Compare the Pharmacokinetics and Safety of Trastuzumab for Injection With Herceptin® in Healthy Male Volunteers

Phase I Clinical Study of Randomized, Double-blind, Single-dose, Parallel Comparison of Trastuzumab for Injection and Herceptin® in Healthy Male Volunteers on Pharmacokinetics and Safety

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 89 (actual)
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Industry
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Trastuzumab for injection is a biosimilar of Herceptin ® produced by Chia Tai Tianqing Biotechnology Co., LTD, which is a humanized IgG1 monoclonal antibody produced by chinese hamster ovary (CHO) cells. A randomized, double-blind, single-dose, parallel phase I study comparing trastuzumab for injection with Herceptin ® in healthy male volunteers was conducted to evaluate the similarities in pharmacokinetics, tolerability, safety and immunogenicity of Trastuzumab for injection and Herceptin®.

Conditions

• Metastatic Breast Cancer
• Metastatic Gastric Cancer

Interventions

Type	Name	Description
DRUG	Trastuzumab for injection	Trastuzumab for injection manufactured by Chia Tai Tianqing. Trastuzumab is a humanized IGG1-class monoclonal antibody produced by CHO cells. Its mechanism of action is to prevent the attachment of human epidermal growth factor to Her2 by attaching itself to Her2, thus blocking the growth of cancer cells. In addition, Trastuzumab can also stimulate the body's own immune cells to destroy cancer cells.
DRUG	Herceptin	Herceptin is the brand name of Trastuzumab for injection manufactured by Roche. Trastuzumab is a humanized IGG1-class monoclonal antibody produced by CHO cells. Its mechanism of action is to prevent the attachment of human epidermal growth factor to Her2 by attaching itself to Her2, thus blocking the growth of cancer cells. In addition, Trastuzumab can also stimulate the body's own immune cells to destroy cancer cells.

Timeline

• Start date: 2017-07-16
• Primary completion: 2017-10-27
• Completion: 2017-10-27
• First posted: 2023-03-13
• Last updated: 2023-03-13

Locations

1 site across 1 country: China