Spots Global Cancer Trial Database for Clinical Study to Compare the Pharmacokinetics and Safety of Trastuzumab for Injection With Herceptin® in Healthy Male Volunteers
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Trial Identification
Brief Title: Clinical Study to Compare the Pharmacokinetics and Safety of Trastuzumab for Injection With Herceptin® in Healthy Male Volunteers
Official Title: 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
Study ID: NCT05765357
Study Description
Brief 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®.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: Yes
Locations
Affiliated Hospital of Changchun University of Traditional Chinese Medicine, Changchun, Jilin, China
Contact Details
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