Based on molecular imaging technology, services scope:
• Clinical study protocol design and drafting;
• Selecting sites to be involved;
• Communication with Ethic committee;
• Sites' monitoring;
• Data management & Statistical analysis;
• Clinical study report design and drafting
Phase 0 trials are first-in-human studies that are conducted prior to traditional dose-finding phase I trials. Phase 0 trials are involved in only a few patients (usually 10-12) who are exposed to a limited number (fewer than 7 days) of low doses of an investigational drug, either microdoses (defined as less than 1/100th of the pharmacologically active dose as determined in an animal models) or sub-therapeutic but pharmacologically active doses.
Phase 0 trials provide a platform to access the pharmacokinetic (PK) and pharmacodynamic (PD) properties of an agent in humans very early in the drug evaluation process. Data generated from such trials can inform the subsequent development of the agent, providing a rational basis for “go” and “not go” clinical decisions.
The objectives of phase 0 trials include:
1.Determining whether the mechanism of action defined in preclinical models can be demonstrated in human;
2.Evaluating PK-PD relationship;
3.Refining a qualified PD assay in human tissues;
4.Optimizing the sequence and schedule of drug combinations;
5.Selecting a lead agent from analogs based on human PK/PD data; and
6.Examining agent biodistribution, binding, and target effects in human, using highly sensitive imagining technologies.
Not all novel agents need to undergo phase 0 testing prior to undergoing traditional phase I evaluation. The commitment to conduct a phase 0 trial should be based on strong preclinical data with clear decision points affecting the future development of the agent. (See below flow chart referred)
MITRO uses PET/SPECT and other molecular imaging technologies to provide phase 0 research services for new drugs. These technologies enable bio-distribution, targeting and mechanism studies of drugs in human bodies in an early research stage, helping drug R&D institutes to make correct decisions quickly and providing important basis for making R&D and investment decisions.