This is a Phase Zero trial.
A Phase O study has nothing to do with safety (or a patent application!) It is all about showing the PK profile of a new dosage form. It needs to be done in healthy volunteers, not in clinical trial patients.
Noxopharm could start a Phase 3 study in 2019 without Phase O data, but that would be outside the US. The Phase O study allows Noxopharm to apply for an IND so that it can conduct trials in the US.
This is a Phase Zero trial. A Phase O study has nothing to do...
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