The concept of microdosing entails administration of an investigational compound to healthy human volunteers at sub-pharmacological levels to provide pharmacokinetic information and ADME profiling of the drug candidate. Regulatory approval for microdose studies requires fewer safety and toxicology assessments than those needed for standard Phase 1 clinical trials and do not require the GMP manufacture of kilogram quantities of the test article.

Conducting a human microdosing study with Corsidus can reduce development costs by selecting the best candidate for further development or provide guidance on “quick kills”.  Microdosing studies cost significantly less than a conventional Phase I trial and can be completed in a much shorter time frame.  Combining initial prerequisite standard safety assessments that must be conducted for traditional IND programs with a limited and focused microdose toxicology program enables regulatory approval for the conduct of a human microdose clinical trial.  Data generated via human microdosing using accelerator mass spectrometry can aid development decisions by providing human ADME/PK profile of the drug candidate prior to the financial commitment to invest in full preclinical safety and toxicology studies, human Phase I trials and beyond.