[Study Completion] Successful Completion of Phase 1 Trial of New Asthma Drug!
01/09/2019
The investigational drug, Benralizumab, is a novel drug for treating asthma. It was approved in USA, European Union, Japan and Canada. HKU Clinical Trials Centre conducted the phase 1 clinical research of the drug to evaluate the metabolism and safety of the drug using different doses in Chinese population.
Recruitment started in March 2019 and 36 healthy volunteers were selected to join the study. The whole study took 17 weeks and it included screening, 3-day-2-night confinement and follow-up visits. Volunteers were divided into 2 groups to receive injection. The research was completed in August 2019.
[Study News] The Phase 1 Novel Drug Clinical Trial conducted at HKU Phase 1 Centre was approved by China FDA!
14/05/2018
[Study News] The Phase 1 Novel Drug Clinical Trial conducted at HKU Phase 1 Centre was approved by China FDA!
14/05/2018
Dr. Hong and Ceci are thrilled to announce that the Phase 1 Novel Drug Clinical Trial conducted at HKU Phase 1 Centre was approved by the China Food and Drug Administration (CFDA)! It proves that the contribution of healthy volunteers are rewarding!
A Phase 1 clinical trial on novel hepatitis C drug was completed at HKU Phase 1 Clinical Trials Centre in 2015. It provided important data on drug metabolism of Chinese people which expedited the completion time of clinical studies in China. The drug could finally be approved by CFDA in April 2018.
The drug received its first global approval from the U.S. Food and Drug Administration (FDA) in January 2016 and subsequently its registration in Hong Kong from the Department of Healthy in January 2018. It took only merely 2 years for the drug to obtain the approval to register in China after its first global approval. More patients could benefit from it and the result was truly encouraging to all.
We would like to thank all healthy volunteers who participated in this clinical study for your precious time and contribution in supporting the drug discovery!
U.S. Food and Drug Administration: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm483828.htm
Department of Health, Hong Kong: http://www.drugoffice.gov.hk/eps/drug/productDetail/en/consumer/98948
