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Phase 1 & Early Phase Trials

Continuous development of new and better medicines is crucial to the development of public health. Clinical trials represent the bridging step in the development of new medicines, bringing potential new medicines from laboratories to the bedside. Phase 1 trials constitute the first step of clinical development, where novel medicines are tested initially in humans.

The HKU Phase 1 Clinical Trials Centre is a purpose-built, 24-bed clinical research facility specifically designed for conducting phase 1, early phase and clinical pharmacology trials. With its dedicated medical and clinical operations teams, the full back-up by specialists of HKU-CTC, and the support by QMH, the HKU Phase 1 Centre is capable of conducting a wide range of phase 1 and early phase clinical trials such as first-in-human (FIH) trials, proof-of-concept (POC) trials and cardiac safety (QT/TQT) trials.

Key Service Capabilities
Dedicated medical team with clinical experts in clinical pharmacology, oncology and other key therapeutic areas
Dedicated clinical operations team composed of professional study coordinators, registered nurses, pharmacists, dispensers and laboratory specialists
Rapid and detailed feasibility assessment coordinated by specialists in business and project intelligence
Protocol development or consultation on protocol development by a professional protocol development team comprising experts in medical/clinical sciences, ethics/regulatory requirements, clinical operations, study budgeting, data management, medical statistics and medical writing
Comprehensive project management capabilities supporting quick study start-up and streamlined study operations
Full support on ethics and regulatory submissions by ethics and regulatory specialists
Efficient budgeting and contracting process facilitated by budgeting and contract specialists (with master clinical trial agreements (Master CTAs) or CTA templates established with over 170 sponsors worldwide)
Strong data management and statistical support by professional data managers and medical statisticians
Full support by the CAP-accredited clinical laboratory in QMH
Pharmacokinetic analysis support by the HKU Pharmacokinetics Laboratory
Access to healthy volunteers and patients in a wide range of disease areas

Safety and Quality Management
Ongoing safety monitoring by staff-on-duty, supported by on-site safety monitoring system and surveillance camera system
On-site medical emergency support by qualified clinical staff, using on-site dedicated resuscitation room, equipment and materials
24-hour medical emergency support by QMH’s central resuscitation team and intensive care unit (ICU)
Robust quality assurance (QA) system established based on the principles of total quality management (TQM)
Intensive internal quality control (QC) for each study
Long-term archiving of study records in professional document storage facilities through HKU-CTC’s ArchiveEasy service

Key Study Capabilities
First-in-human (FIH) trials
Phase1a/1b and Phase 1b/2a trials
Proof-of-concept (POC) trials
Pharmacokinetics (PK) trials
Cardiac safety (QT/TQT) trials
Drug-drug, food-drug interaction trials
Vaccine trials