A pharmacokinetic study to comparatively evaluate the bioequivalence and safety of a humanized recombinant monoclonal antibody targeting human epidermal growth factor receptor-2 with the reference Herceptin in healthy Chinese subjects

Conclusion. The 90% CI value of Cmax and AUC0-t for QLHER2/Herceptin ratio ranged between 80.0% –125.00%, indicating that QLHER2 was bioequivalent to Herceptin. These results support further evaluation of QLHER2. Trial registration number: ChiCTR2000041577 and ChiCTR2100041802. Date of registration: 30th December, 2020 and 5th January 2021.
Source: Investigational New Drugs - Category: Drugs & Pharmacology Source Type: research