Purpose of Phase 1 Clinical Drug Trial

• A. Long-term safety
• B. Efficacy and adverse effects
• C. Safety and dosage
• D. Manufacturing feasibility

Answer: (C)

Phase 1 trials are the first time a drug is tested in humans, and the main aim is to establish safety and find an appropriate dose range. Researchers monitor how the drug behaves in the body—pharmacokinetics and pharmacodynamics—while looking for any adverse effects and tolerability. This helps determine a safe starting dose, how dosing can be expanded to a range of levels, and the maximum dose that patients can tolerate without unacceptable safety issues. The results set the foundation for Phase 2, where efficacy is explored at selected doses. Long-term safety data and efficacy are not the primary focus at this stage, and manufacturing feasibility isn’t the trial’s main objective.