Neoplasms

Digestive System Diseases

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Skin and Connective Tissue Diseases

Rare Diseases

Stomach Neoplasms

Breast Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

All Drugs and Chemicals

Antineoplastic Agents

Antibodies

Antibodies, Monoclonal

Trastuzumab

Immunoglobulins

Mitogens

Antineoplastic Agents, Immunological

4mg/kg, Single dose for intravenous infusion

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.

Trastuzumab for injection

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.

Herceptin

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®.

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

Area under the curve from time zero to the lowest detectable blood drug concentration

The area under the curve extrapolating from time zero to infinity

Time to reach maximum plasma concentration after dosing

Percentage of the body that eliminates organ-scavenging drugs

The time it takes for serum drug concentrations to drop by half

Apparent volume of distribution after administration

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Clinical Study to Compare the Pharmacokinetics and Safety of Trastuzumab for Injection With Herceptin® in Healthy Male Volunteers	NCT05765357	Metastatic Brea... Metastatic Gast...	Trastuzumab for... Herceptin	18 Years - 65 Years	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Clinical Study to Compare the Pharmacokinetics and Safety of Trastuzumab for Injection With Herceptin® in Healthy Male Volunteers	NCT05765357	Metastatic Brea... Metastatic Gast...	Trastuzumab for... Herceptin	18 Years - 65 Years	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Spots Global Cancer Trial Database for trastuzumab for injection