[Study Completion] Phase 1 Clinical Trial of a New Autoimmune Disease Drug Was Completed!
01/12/2020
[Study Completion] Phase 1 Clinical Trial of a New Autoimmune Disease Drug Was Completed!
01/12/2020
HKU Clinical Trials Centre was delegated to research on a novel drug for treating autoimmune diseases. Phase 1 trial of the drug was conducted in Canada earlier but the research purpose was to evaluate the metabolism and safety of the drug at dose escalation in Chinese population.
Recruitment started in May 2019 and 24 qualified healthy volunteers were selected after screening. The 18-week research was divided into 3 cohorts and each volunteer only joined one of them. The volunteers received injection during their 6-day-5-night stay in the Centre. As the duration of overnight stay was long, two workshops were organized, namely Spark Chamber and Mini Neon Light DIY Workshops.
The clinical study was successfully completed in November 2020.
[Study News] Clinical Studies of COVID-19
05/03/2020
To help identify possible treatments for tackling COVID-19, The University of Hong Kong Clinical Trials Centre join forces with Queen Mary Hospital, Prince of Wales Hospital, Princess Margaret Hospital and the manufacturer of remdesivir, an investigational antiviral drug, in arranging for two clinical trials targeting for the treatment of moderate to severe COVID-19 patients. With a common goal of accelerating the preparation for the trials, the parties have been working hard in the past few weeks and quickly obtained the approvals from the research ethics committees. It is anticipated that the trials will be initiated within this month (i.e. March 2020).
[Study Completion] Successful Completion of Phase 1 Clinical Trial for Anesthetic!
31/01/2020
[Study Completion] Successful Completion of Phase 1 Clinical Trial for Anesthetic!
31/01/2020
The investigational drug of this study is EXPAREL®, a local anesthetic, which was approved by the US Food and Drug Administration (FDA) in 2011 on postsurgical pain relief. HKU-CTC was delegated to perform this study to evaluate the metabolic and safety profiles of this drug in Chinese population.
Recruitment of this study started in October 2019, and 20 healthy volunteers were recruited. The duration of this clinical study was around 54 days, including screening, 6-night confinement, ambulatory visits and a follow up phone call. During the study period, volunteers received one dose of the investigational drug via subcutaneous injection at multiple points. Due to the long staying period, HKU-CTC organized 3 workshops for the healthy volunteers, including Turkish Mosaic Lamp Workshop, Little Paper Art Night Lamp Workshop and Art of Paper Tearing Workshop. The project was completed in January 2020.
[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
