Clinical Phase I Study definition

Clinical Phase I Study means a study in humans which provides for the first administration to humans of a product, conducted in healthy volunteers or patients to obtain information on product safety, tolerability, pharmacological activity or pharmacokinetics, as more fully defined in 21 C.F.R. § 312.21(a) or the non-United States equivalent thereof. For the avoidance of doubt, a Clinical Phase I Study may generate sufficient data (if successful) to commence pivotal studies/Clinical Phase III Studies, but it shall not constitute a Clinical Phase II Study.
View Source
Clinical Phase I Study means a clinical study of a product as further defined in 21 CFR §312.21(a) or the non-United States equivalent thereof. A Clinical Phase I Study is a clinical study in humans, the primary objective of which is to determine preliminary safety in healthy volunteers or patients. Such clinical study may also have secondary objectives, including tolerability, pharmacological activity or pharmacokinetics and preliminary efficacy parameters and may therefore be regarded as a phase I/II clinical trial. For the purposes of this Agreement, (i) the term Clinical Phase I Study shall also cover such phase I/II clinical trial; and (ii) at the point in such study when the cohort is expanded beyond the original phase I/II design so that the study becomes prospectively designed to generate sufficient data (if successful) to commence a Pivotal Study, a Clinical Phase II Study shall be deemed to have commenced.
View Source

Examples of Clinical Phase I Study in a sentence

  • The Parties shall jointly work on the Development of such Product up to and including the Clinical Phase I Study and, unless the Program is terminated, GSK will conduct all subsequent Development activities, including activities to obtain Regulatory Approval for such Product, which CureVac shall support, including by the clinical supply of Products, all in accordance with this Agreement and the applicable R&D Plan.

  • CureVac will complete preclinical validation and sponsor a Clinical Phase I Study of this First Product, unless the Parties agree on a different clinical Development approach within the JSC.

Related to Clinical Phase I Study

  • Phase I Study means a human clinical trial in any country that would satisfy the requirements of 21 C.F.R. § 312.21(a) (FDCA), as amended from time to time, and the foreign equivalent thereof.

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • Phase II Clinical Study means a human clinical study of a product initiated to determine the safety and efficacy in the target patient population, as described 21 C.F.R. 312.21(b).

  • Phase I Clinical Trial means a human clinical trial that is intended to initially evaluate the safety and/or pharmacological effect of a Product in subjects or that would otherwise satisfy requirements of 21 C.F.R. 312.21(a), or its foreign equivalent.

  • Phase III Clinical Study means a human clinical study of a product on a sufficient number of subjects that is designed to establish that such product is safe and efficacious for its intended use, and to determine warnings, precautions, and adverse reactions that are associated with such product in the dosage range to be prescribed, which trial is intended to support Regulatory Approval of such product, as described in 21 C.F.R. 312.21(c). 1.185. [***] 1.186. [***]