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[Early clinical drug development]

Christian Funck-Brentano1

  • 1Sorbonne université, Inserm CIC Paris-Est, AP-HP, ICAN, service de pharmacologie médicale, groupe hospitalier La Pitié-Salpêtrière, Paris, France.

La Revue Du Praticien
|October 19, 2019
PubMed

Insights

Phase I drug development studies assess a new molecule's safety and effects in humans. These highly regulated trials in healthy volunteers or cancer patients determine pharmacokinetic and pharmacodynamic profiles.

Area of Science:

  • Pharmacology
  • Clinical Trials
  • Drug Development

Background:

  • Phase I studies are the first human administration of a drug candidate.
  • They follow animal studies assessing pharmacology and toxicity.
  • These trials are crucial for initial human safety assessment.

Purpose of the Study:

  • To evaluate the safety and tolerability of a new molecule in humans.
  • To determine the pharmacokinetic and pharmacodynamic profiles of the drug.
  • To explore variability in drug response among participants.

Main Methods:

  • Administration of single and repeated doses to healthy subjects or cancer patients.
  • Conducted in authorized medical centers by trained professionals.
  • Adherence to highly regulated and standardized methodologies.

Main Results:

  • Initial assessment of pharmacological effects and toxicity in humans.
  • Characterization of how the body processes the drug (pharmacokinetics).
  • Understanding the drug's effects on the body (pharmacodynamics).

Conclusions:

  • Phase I studies are essential for establishing human safety.
  • Standardized protocols ensure reliable data collection.
  • These trials provide foundational data for further drug development.
Keywords:
Drug Development

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