Pooled analysis of routine safety parameters observed in healthy participants at baseline and following placebo administration in early phase clinical studies.

ABSTRACT: Phase I trials inform on the initial safety profile of a new molecule and impact whether further development is pursued or not. Understanding the effect of non-pharmacological factors on the variability of routine safety parameters could improve decision making in these early clinical trials, helping to separate signals related to the new molecule from background "noise." To understand the impact of non-pharmacological factors on routine safety parameters, we evaluated pooled safety data from over 1000 healthy participants treated with placebo in phase I trials between 2009 and 2018. The phase I participants were predominantly men, less than or equal to 50 years, White, and non-Hispanic; and approximately an equal proportion had body mass index in the normal and overweight/obese range. Fol

SUBMITTER: Duncan KE 

PROVIDER: S-EPMC10777607 | biostudies-literature | 2024 Jan

REPOSITORIES: biostudies-literature