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Phase II 0 studies

Phase II0 proof-of-concept mechanistic studies

 

  • Phase II0 clinical study is a proof-of-concept study that allows critical testing of presumed mechanism of action in a limited number of healthy human subjects or patients
  • Extremely useful in the "go/no-go" decision process after successful phase I and before phase II
  • An example of study would be: "A Randomized, Double Blind, Placebo-Controlled Study to Assess the Electrophysiological Effects of XX in Patients with Diabetic Painful Neuropathy”
  • Expertise in painful neuropathies: Diabetic, traumatic, small fiber neuropathies