Phase of clinical trials that tests a drug on healthy volunteers to confirm safety and likely therapeutic dose is called which phase?

Phase of clinical trials that tests a drug on healthy volunteers to confirm safety and likely therapeutic dose is called which phase?

• A. Phase 0
• B. Phase 1
• C. Phase 2
• D. Phase 3

Answer: (B)

This stage focuses on safety and how the drug behaves in the body, using healthy volunteers to find a safe starting dose and understand tolerability. It involves small groups and looks at adverse effects, how the drug is absorbed, distributed, metabolized, and excreted, and what dose range seems safe. This helps establish initial safety data and an appropriate dose for later patient studies. Other phases serve different purposes: Phase 0 uses microdoses to gather early pharmacokinetic data; Phase 2 tests efficacy and optimal dosing in patients who have the condition; Phase 3 confirms safety and efficacy in larger patient groups before regulatory review. Therefore, the described stage is Phase 1.

This stage focuses on safety and how the drug behaves in the body, using healthy volunteers to find a safe starting dose and understand tolerability. It involves small groups and looks at adverse effects, how the drug is absorbed, distributed, metabolized, and excreted, and what dose range seems safe. This helps establish initial safety data and an appropriate dose for later patient studies.

Other phases serve different purposes: Phase 0 uses microdoses to gather early pharmacokinetic data; Phase 2 tests efficacy and optimal dosing in patients who have the condition; Phase 3 confirms safety and efficacy in larger patient groups before regulatory review. Therefore, the described stage is Phase 1.