TAIPEI, Taiwan, Feb. 07, 2022 – TaiGen Biotechnology announced that the enrollment of TG-1000 phase II trial has been completed. TaiGen said that they have enrolled 202 subjects in the trial. The clinical team has gone through many challenges in the process of patient recruitment during the outbreak of COVID-19. It’s excited that the team conquered all these challenges.
Kuo-Lung Huang, the Chairman and CEO of TaiGen indicates that our team has to implement the clinical trial of the US and China requirement since the TG-1000 INDs were granted by both the US and China authorities. He emphasizes, “TaiGen has known for the quality of clinical trial, the trial design, process and requirement are under the US FDA guideline and standard.“
It cost much more time to recruit patients as the outbreak of COVID-19. To prevent the infection of COVID-19, the number of influenza patients thereby decreased significantly. Furthermore, the subject screening is much more complicated and strictly than in previous years. TaiGen said that every patient has to been screened by both influenza rapid test and COVID-19 PCR tests to exclude COVID-19 infected patients.
The purpose of phase II study is the evaluation of effectiveness, safety and pharmacokinetics. The study design is a multi-center, randomized, double-blinded, placebo controlled and dose exploring study. About a total of 200 health volunteers are expected to be enrolled in Phase II clinical study in 30 clinical research centers.