Phase I

Phase I clinical trials are usually the first trials that involve humans. The main purpose of Phase I trials is to obtain initial information about the safety, tolerability, and pharmacokinetics of a drug candidate. Phase I trials are conducted in a small group of healthy volunteers and/or patients.

Phase I trials:

• First-in-Human
  • Single ascending dose
  • Multiple ascending dose
• Food interaction studies
• Drug-Drug interaction (DDI) studies
• Bioavailability and Bioequivalence studies
• Pharmacokinetics/Pharmacodynamics (PK/PD)
• TQT studies
• ADME
• Hepatic impairment
• Renal impairment