Phase-0 Clinical Trial
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A Phase-0 Clinical Trial is a human exploratory clinical trial that is conducted to study the pharmacokinetics of a new drug/agent by testing whether it behaves in human subjects as was expected from preclinical trials.
- AKA: Human Microdosing Clinical Trial, Early Phase-I Clinical Trial.
- Context:
- It includes the administration of single subtherapeutic doses of the drug.
- It can (typically) involve 10-15 human test subjects.
- …
- Example(s):
- Counter-Example(s):
- See: Parallel Clinical Trial, Factorial Clinical Trial, Large-Simple Clinical Trial, Adaptive Clinical Trial.
References
2022a
- (Wikipedia, 2022) ⇒ https://en.wikipedia.org/wiki/Phases_of_clinical_research#Phase_0 Retrieved 2022-01-15.
- QUOTE: Phase 0 is a recent designation for optional exploratory trials conducted in accordance with the United States Food and Drug Administration's (FDA) 2006 Guidance on Exploratory Investigational New Drug (IND) Studies.[1] Phase 0 trials are also known as human microdosing studies and are designed to speed up the development of promising drugs or imaging agents by establishing very early on whether the drug or agent behaves in human subjects as was expected from preclinical studies. Distinctive features of Phase 0 trials include the administration of single subtherapeutic doses of the study drug to a small number of subjects (10 to 15) to gather preliminary data on the agent's pharmacokinetics (what the body does to the drugs).[2]
A Phase 0 study gives no data on safety or efficacy, being by definition a dose too low to cause any therapeutic effect. Drug development companies carry out Phase 0 studies to rank drug candidates in order to decide which has the best pharmacokinetic parameters in humans to take forward into further development. They enable go/no-go decisions to be based on relevant human models instead of relying on sometimes inconsistent animal data.[3]
- QUOTE: Phase 0 is a recent designation for optional exploratory trials conducted in accordance with the United States Food and Drug Administration's (FDA) 2006 Guidance on Exploratory Investigational New Drug (IND) Studies.[1] Phase 0 trials are also known as human microdosing studies and are designed to speed up the development of promising drugs or imaging agents by establishing very early on whether the drug or agent behaves in human subjects as was expected from preclinical studies. Distinctive features of Phase 0 trials include the administration of single subtherapeutic doses of the study drug to a small number of subjects (10 to 15) to gather preliminary data on the agent's pharmacokinetics (what the body does to the drugs).[2]
- ↑ CDER (2006) "Exploratory IND Studies".Guidance for Industry, Investigators, and Reviewers. Food and Drug Administration. Retrieved: 2010-06-15.
- ↑ Lancet (July 2009). “Phase 0 trials: a platform for drug development?" Lancet 374(9685):176. PMID:19616703 DOI:10.1016/S0140-6736(09)61309-X. S2CID:30939770.
- ↑ Tal Burt, Tal; Young, Graeme,Lee; Wooin; Kusuhara, Hiroyuki; Langer, Oliver; Rowland, Malcolm; Sugiyama, Yuichi (2020). “Phase 0/microdosing approaches: time for mainstream application in drug development?". Nature Reviews Drug Discovery 19(11):801–818. DOI:10.1038/s41573-020-0080-x. PMID:32901140. ISSN:1474-1784
2022b
- (ClinicalTrials.gov, 2021) ⇒ https://clinicaltrials.gov/ct2/about-studies/glossary Retrieved 2022-01-15.
- QUOTE: Early Phase 1 (formerly listed as Phase 0): A phase of research used to describe exploratory trials conducted before traditional phase 1 trials to investigate how or whether a drug affects the body. They involve very limited human exposure to the drug and have no therapeutic or diagnostic goals (for example, screening studies, microdose studies).