News

[Study News] HKU medical research team starts large-scale clinical trial on COVID-19 Vaccine (Omicron Variant)

09/06/2022

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[Study News] HKU medical research team starts large-scale clinical trial on COVID-19 Vaccine (Omicron Variant)

09/06/2022

A medical research team from the University of Hong Kong (HKU) started a large-scale clinical trial on a new COVID-19 inactivated vaccine (Omicron variant). The study is led by Professor Ivan Hung, Chief of Division of Infectious Diseases and Clinical Professor of Department of Medicine, LKS Faculty of Medicine, the University of Hong Kong (HKUMed) and HKU Clinical Trials Centre (HKU-CTC) is responsible for coordination and technical support.

A press conference was held on 31st May, 2022 to share with the public more about the details of the clinical trial. Professor Ivan Hung, Dr. Kelvin To (Chairperson and Clinical Associate Professor of Department of Microbiology, HKUMed) and Mr. Henry Yau (Managing Director of HKU-CTC) were invited. For more details about the press conference, please visit: https://hku.hk/press/news_detail_24616.html

As thousands of volunteers are needed for this study, if you are interested to join, please register via the link below:
https://redcap.link/joinctc2298

[Volunteer Recruitment] Sequential Vaccination Study Against COVID-19 caused by the Omicron variant - It's now inviting volunteers to join!

11/05/2022

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[Volunteer Recruitment] Sequential Vaccination Study Against COVID-19 caused by the Omicron variant - It's now inviting volunteers to join!

11/05/2022

HKU-CTC is now inviting volunteers to join a sequential vaccination study against COVID-19 caused by the SARS-CoV-2 Omicron variant. The purpose of this clinical study is to investigate the safety and immunogenicity profile of three (3) types of investigational inactivated vaccines (BIBP, WIBP or Prototype Vaccine) in populations who have received 2 or 3 doses of COVID-19 vaccines. The study will be conducted in the Vaccination Centre located in Sun Yat Sen Memorial Park Sports Centre in Sai Ying Pun (“Vaccination Centre”).

Please note that the service hour of our Centre will be extended to 6:30pm on 8th, 22nd Sep 2022 (Thu). 

In support of the clinical development of COVID-19 vaccines, the Hong Kong Government agrees to issue a ‘Provisional Vaccine Pass’ to each participant successfully enrolled in this study, and it will be valid during the entire study period until the vaccines used in this study (both Omicron and Prototype) are approved by regulatory authorities. The ‘Provisional Vaccine Pass’ would allow its holders to enter or remain on premises subject to the ‘Vaccine Pass’ requirement.

For the detailed information, please visit: https://public.hkuctc.com/en/projects/detail/CTC2298

If you are interested to join this study, please register at the following link (study number CTC2298):
https://redcap.link/joinctc2298

 

[Study News] Now News Report: Phase 1 clinical trial of HKU intranasal COVID-19 vaccine has commenced (May 15, 2021)

10/06/2021

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[Study News] Now News Report: Phase 1 clinical trial of HKU intranasal COVID-19 vaccine has commenced (May 15, 2021)

10/06/2021

Now News visited HKU Phase 1 Clinical Trials Centre earlier to produce a report on the process and progress of the phase 1 clinical trial of “VectorFlu ONE”. Here is the report by Now News (Chinese only):

[Study News] Phase 1 clinical trial of VectorFlu ONE, COVID-19 nasal vaccine, has commenced!

14/05/2021

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[Study News] Phase 1 clinical trial of VectorFlu ONE, COVID-19 nasal vaccine, has commenced!

14/05/2021

The phase 1 clinical trial of VectorFluTM ONE, the world’s first COVID-19 nasal vaccine developed by the research team of HKU Department of Microbiology, has commenced in March 2021 at the HKU Phase 1 Clinical Trials Centre. About 115 healthy volunteers will be recruited to evaluate the safety and immune responses of the vaccine.

VectorFluTM ONE is the first novel vaccine that is developed by Hong Kong and goes into human trial. The phase 1 trial will last for around 1.5 years. Part 1 of the trial has commenced in March 2021, where about 30 volunteers have already received one or two vaccinations. Part 2 will begin in July 2021 and 85 volunteers will be recruited. We are still looking for more volunteers to join.

[Study Completion] Successful Completion of Generic Drug Study Indicated for Hyperlipidemia!

30/12/2020

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[Study Completion] Successful Completion of Generic Drug Study Indicated for Hyperlipidemia!

30/12/2020

The recruitment of this study started in July 2020 and 52 healthy volunteers were recruited.  This clinical study consisted of 2 parts (fasted and fed), and each volunteer only joined either one part. The duration of each part was around 4-6 weeks, including screening, confinement and follow up visits.  Although the study process was slightly postponed due to the COVID-19 pandemic, thanks to the genuine support from our volunteers and the effort of our HKU professional research team, the project was completed safely and efficiently in November 2020.

[Study Completion] Phase 1 Clinical Trial of a New Autoimmune Disease Drug Was Completed!

01/12/2020

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[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

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[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

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[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

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[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

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[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