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Good Clinical PracticeICH E6(R3) from the ground up, with a free verifiable completion record.2 courses · ~25h · Optional paid certificate

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Phase I: First-in-Human Studies — Clinical Research Foundations

Good Clinical Practice (GCP)Course 1 of 2

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Clinical Research Foundations
Phase I: First-in-Human Studies

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Phase I: First-in-Human Studies

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Good Clinical Practice (GCP)

Full course · Clinical Research Foundations

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Good Clinical Practice (GCP)1 of 2

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This lesson is part of a complete GCP track — 2 courses, quizzes, a final exam, and a free verifiable credential. The optional $29 PDF certificate is recognized by 18+ trial sponsors.

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Phase I: First-in-Human Studies

Understand why Phase I trials are the critical first step in human testing, who participates, and how dose escalation protects the earliest volunteers.

20 min

What you will learn7 objectives

By the end of this lesson, you will be able to:

Define the primary purpose of Phase I clinical trials and explain why safety is the paramount concern
Identify who typically participates in Phase I studies and explain the rationale for participant selection
Describe common Phase I study designs, including Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) approaches
Explain dose escalation methods such as the 3+3 design and Bayesian adaptive approaches
Define Maximum Tolerated Dose (MTD) and explain how it guides dose selection for later trials
Identify the key pharmacokinetic and pharmacodynamic parameters measured in Phase I studies
Recognize the specialized environments and intensive monitoring requirements of first-in-human studies

Timed blood samples are collected throughout Phase I trials to map the drug's absorption and elimination (pharmacokinetics). — FigureTimed blood samples are collected throughout Phase I trials to map the drug's absorption and elimination (pharmacokinetics).

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