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Phase I clinical trials are the first step in the clinical trial process. They are designed to assess the safety and tolerability of a new drug or treatment in a small group of healthy volunteers or patients. The primary objective of Phase I trials is to determine the maximum tolerated dose (MTD) of the drug or treatment, as well as to identify any side effects or adverse events associated with its use. The data collected from Phase I trials is used to inform the design of subsequent Phase II and Phase III trials.
Phase I trials are typically conducted by contract research organizations (CROs) on behalf of pharmaceutical and biotechnology companies. These companies are responsible for the development and commercialization of new drugs and treatments. Examples of companies in the Phase I trial market include Parexel, Quintiles, Covance, and PPD. Show Less Read more