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Brief Title: Clinical Trial of Comparative Study of GB221 Pharmacokinetics
Official Title: A Randomized, Double-blind, Parallel-group, Comparative Phase I Study to Evaluate the Safety and Pharmacokinetics of Single Intravenous (IV) Administration of GB221 Versus Herceptin® (Trastuzumab)
Study ID: NCT04175171
Brief Summary: The primary objective is to assess the safety of a single dose of GB221 compared to Herceptin® when administered as a single IV injection at a dose of 8 mg/kg. The secondary objective of the study is to assess the pharmacokinetics of GB221 compared to Herceptin®.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT
Sex: MALE
Healthy Volunteers: Yes
Linear Clinical Research Limited, Nedlands, Western Australia, Australia
Name: Andrewn Redfer, PhD; MBBS
Affiliation: Linear Clinical Research Limited
Role: PRINCIPAL_INVESTIGATOR