CRED Understanding Clinical Development 2024

11/10/2024

Phase I - First in Human Studies in Healthy Volunteers Overall objectives:

Safety and Tolerability

Pharmacodynamics – Biomarkers and Adverse Events

Pharmacokinetics – single and multiple dose

Single and Multiple Ascending Dose studies

Subjects

Healthy volunteers – Patients sometimes in oncology

Enable assessment and understanding of:

Variability within & between subjects

Identify the exposure or dose that relates to toxicity or adverse events

Generate data to inform dose and dosing regimen in later phases

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PK Sampling In Phase I

Serial sampling taken from each individual

Sampling designed to ensure good definition of the C max and T max , AUC and the terminal phase of the curve (half-life - t 1/2 ).

Detailed description of a relatively small number of individuals

Estimate the average of relevant PK parameter, with variablity across individuals for various doses

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