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

PHASE1CompletedINTERVENTIONAL
Enrollment

89

Participants

Timeline

Start Date

July 16, 2017

Primary Completion Date

October 27, 2017

Study Completion Date

October 27, 2017

Conditions
Metastatic Breast CancerMetastatic Gastric Cancer
Interventions
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.

Trial Locations (1)

130021

Affiliated Hospital of Changchun University of Traditional Chinese Medicine, Changchun

All Listed Sponsors
lead

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

INDUSTRY