[Drug research. First into human in phase I]

Area of Science:

• Pharmacology
• Clinical Research
• Drug Development

Context:

• Phase I clinical trials are crucial for introducing new chemical entities to humans.
• These trials typically involve healthy volunteers to assess initial safety and tolerability.
• Early Phase I, specifically "first into human" studies, are the focus.

Purpose:

• To describe the processes, technical, medical, and regulatory requirements for conducting "first into human" trials.
• To address key considerations such as formulation, route of administration, and participant selection.
• To review literature on determining the initial safe dose and dose escalation strategies.

Summary:

• Early Phase I trials evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of new drugs in humans.
• The article outlines pre-trial processes and requirements for conducting these initial human studies.
• It discusses dose-escalation schemes, maximum tolerated dose identification, and first-dose determination.

Impact:

• Provides essential guidance for researchers and regulatory bodies involved in early-stage drug development.
• Contributes to the safe and effective progression of novel therapeutic agents through clinical evaluation.
• Enhances understanding of the critical factors influencing the success of initial human drug trials.