Phase 1 clinical trials are designed to test a new therapy in a small group of people for the first time to evaluate safety (e.g., to determine a safe dosage range and to identify adverse effects). It can include healthy participants or patients.
National Institute on Aging (NIA) Glossary of Clinical Research Terms
U.S. Food and Drug Administration (FDA) The Drug Development Process: Step 3 Clinical Research
NCATS Toolkit for Patient-Focused Therapy Development: Clinical Trials
NCATS Toolkit for Patient-Focused Therapy Development: Educating Your Disease Community