Phase 0 clinical trial
Introducing Innovative technology into China
Confusions in Phase I~IV
Unpredictable drug toxicity makes 75% R&D investment wasted in early clinical phases.
Unable to accurately speculate the starting dose of a drug used in the human body for clinical trials, making around 40% drugs eliminated at Phase I clinical trial.
Difficult to use animal experiments to accurately predict pharmacokinetic and toxicological data in human body, causing effective compounds wrongly eliminated.
To accelerate drug R&D, European Medicines Evaluation Agency (EMEA) and U.S. Food and Drug Administration (FDA) issued relevant guidance, respectively in July 2003 and January 2006, putting forward a new way for drug R&D: phase 0 clinical trial.
In June 2007, Abbott successfully completed the phase 0 clinical trial of new drug (ABT-888) for the first time worldwide, which accelerated its development by reducing nearly one year R&D time.
The very first CRO company in China to perform phase 0 clinical trials.
We have worked in close collaboration with Beijing Shijitan Hospital to implement the first domestic phase 0 clinical trial, thus successfully introducing this innovative technology into China.
What is phase 0?
Phase 0 is also known as Human Microdosing Study. It refers to collecting data of drug safety and pharmacokinetic tests through limited size and population before the new drug officially starts clinical trials, in order to establish early clinical decision-making mode for new drug R&D.
How can phase 0 help me?
Reduce R&D costs
Shorten R&D cycle
Reduce R&D risks
Screen valuable compounds rapidly
Increase new drug R&D efficiency
Promote effective compounds to reach the market quickly
Which fields does phase 0 apply to?
R&D of innovative anti-tumor drugs with high toxicity
Long treatment window
Expect to adjust the efficacy under the condition of low dosage and short exposure
Assess the targeted effect of the efficacy in a relative small size of samples