Question

Healthy Human volunteers part of which clinical trial phase?

• A. Phase 1
• B. Phase 0
• C. Phase 3
• D. Phase 4

Answer 1

The Correct Option is A

Step 1: Drug development moves from preclinical work into staged human trials, and the very first human exposure is designed to check that the molecule is safe before efficacy is studied.
Step 2: That first-in-human safety and pharmacology study is Phase I, and it recruits healthy volunteers so that the drug effect is not confounded by disease.
Step 3: Later phases enrol patients: Phase III for large-scale efficacy and Phase IV for surveillance after marketing, while Phase 0 is a tiny micro-dose exploratory step, not the volunteer safety phase intended here.
Step 4: The phase that uses healthy human volunteers is therefore Phase 1.
\[\boxed{\text{Phase 1}}\]