Phase 0 clinical trials
Citation, DOI, disclosures and article data
Citation:
Gaillard F, Knipe H, Phase 0 clinical trials. Reference article, Radiopaedia.org (Accessed on 27 Mar 2025) https://doi.org/10.53347/rID-30061
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30061
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Disclosures:
At the time the article was created Frank Gaillard had no recorded disclosures.
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At the time the article was last revised Henry Knipe had no recorded disclosures.
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Phase 0 clinical trials are the first step in evaluating a possible new drug on humans, and are designed to evaluate the pharmacodynamics and pharmacokinetics of the drug in humans. They are typically performed on a small number of subjects (e.g. a dozen or so) who are administered subtherapeutic doses 1.
References
- 1. Phase 0 trials: a platform for drug development?. Lancet. 2009;374 (9685): 176. doi:10.1016/S0140-6736(09)61309-X - Pubmed citation
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