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

In pharmacology, the development of new drugs involves several phases of clinical trials. Each phase serves a specific purpose in evaluating the drug's safety and efficacy:

• Phase 0: These are exploratory studies involving very limited human exposure and have no therapeutic or diagnostic intent. Therefore, healthy volunteers may be included, but the main focus is not on their health outcomes.
• Phase 1: In this phase, the primary goal is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of a drug. This is often done with healthy human volunteers, making this phase about determining appropriate dosage and identifying side effects.
• Phase 3: This phase involves large-scale testing to confirm efficacy, monitor side effects, and compare the drug to commonly used treatments. It usually involves patients who have the condition the drug is meant to treat rather than healthy volunteers.
• Phase 4: These trials are conducted after the drug has been approved for consumer sale, mainly to gather information on the drug's effect in various populations and any side effects associated with long-term use. Like Phase 3, this also involves patients rather than healthy volunteers.

From this breakdown, the correct option for the phase in which healthy human volunteers are involved is Phase 1.