Phase-I: A group of ~60 people (example purposes only). Once group of 20 people receive a small dose of medication. Another group of 20 gets a medium dose, and the last group of 20 receives a higher dose. If results are promising and a Phase-2 is warranted/funded, this phase determines the ideal dose.
Phase-II: A broader group of people, 100-300. All receive the same dose to assess efficacy and safety. If Phase-3 is warranted/funded:
Phase-III: A broader group of people, 1000-2000. Assess efficacy, effectiveness and safety… but some may receive placebos... we think : )
Next steps: Final Christmas shopping and embracing family and friends over the holiday season!