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💊intro to pharmacology review

Phase I Clinical Trials

Written by the Fiveable Content Team • Last updated September 2025
Written by the Fiveable Content Team • Last updated September 2025

Definition

Phase I clinical trials are the first stage of testing a new drug or treatment in humans, primarily focusing on assessing safety, tolerability, and pharmacokinetics. This phase typically involves a small group of healthy volunteers or patients and aims to determine the appropriate dosage and identify any side effects, laying the groundwork for subsequent phases of clinical development.

5 Must Know Facts For Your Next Test

  1. Phase I trials usually involve 20 to 100 participants and can last several months.
  2. The primary goal is to assess safety and tolerability rather than efficacy.
  3. These trials help researchers understand how the drug behaves in the human body, including its pharmacokinetics.
  4. If the results from Phase I are promising, the drug moves on to Phase II trials where its efficacy is tested more rigorously.
  5. Participants in Phase I trials may be compensated for their time and involvement in the study.

Review Questions

  • What are the primary objectives of Phase I clinical trials and how do they set the stage for later phases?
    • The primary objectives of Phase I clinical trials are to evaluate the safety, tolerability, and pharmacokinetics of a new drug. By testing a small group of healthy volunteers or patients, researchers can identify side effects and determine appropriate dosages. The data collected during this phase is crucial for establishing a foundation for Phase II trials, which focus on assessing the drug's effectiveness.
  • Discuss the ethical considerations involved in conducting Phase I clinical trials with human participants.
    • Conducting Phase I clinical trials involves several ethical considerations, primarily ensuring informed consent from participants. Volunteers must fully understand the risks associated with the trial and what participation entails. Additionally, researchers must prioritize participant safety by monitoring adverse effects closely and having protocols in place for managing any complications that arise during the trial.
  • Evaluate how findings from Phase I clinical trials influence drug development and public health outcomes.
    • Findings from Phase I clinical trials play a critical role in drug development as they provide essential information on safety and dosage that informs further research stages. If a drug demonstrates acceptable safety profiles in this phase, it can advance to larger studies that assess efficacy. This progression ultimately affects public health outcomes by determining which new therapies may become available for treating various conditions, thereby impacting treatment options for patients.