phase I

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Definition

Noun: A Phase I clinical trial is the first stage of testing a new drug or invasive medical device in a small group of human volunteers. Its primary purpose is to evaluate the safety profile, determine a safe dosage range, and identify potential side effects or toxicity.

Usage

This term is used specifically in the context of medical research, drug development, and regulatory processes. - It is typically written with a Roman numeral (Phase I) or as "Phase 1". - It functions as a compound noun, often used attributively before other nouns (e.g., Phase I trial, Phase I study).

Examples
  • As a subject:
    • Phase I was successfully completed, showing the drug was well-tolerated in healthy volunteers.
  • Used attributively:
    • The researchers are recruiting participants for the Phase I clinical trial.
    • Safety data from the Phase I study will guide the design of Phase II.
Advanced Usage
  • "to enter Phase I": To begin the first stage of clinical testing in humans.
    • The experimental vaccine is expected to enter Phase I next month.
  • "Phase I/II trial": A clinical trial design that combines elements of both Phase I and Phase II objectives, often to accelerate development.
Variants and Related Words
  • Phase 1: An alternative numerical form with the same meaning.
  • Phase I study, Phase I trial: Common full compound terms.
  • First-in-human (FIH) study: A closely related term often used synonymously with Phase I trials for drugs.
  • Clinical trial: The broader category of research in which a Phase I trial is the initial stage.
  • Phase II, Phase III, Phase IV: Subsequent stages of clinical development.
Synonyms
  • Early-stage clinical trial
  • First-in-human study (specifically for drugs)
  • Safety trial
Related Phrases
  • Dose-escalation study: A common design within a Phase I trial where participants receive incrementally higher doses to find the maximum tolerated dose.
  • Healthy volunteer study: Many Phase I trials are conducted on healthy participants to assess initial safety, though some (e.g., for cancer drugs) use patient volunteers.
Noun
  1. a clinical trial on a few persons to determine the safety of a new drug or invasive medical device; for drugs, dosage or toxicity limits should be obtained

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