Phase I Clinical Study definition

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 I Clinical Study means, as to a particular Licensed Product, an initial clinical study in humans with the purpose of assessing the Licensed Product’s safety, tolerability, toxicity, pharmacokinetics or other pharmacological properties.

Phase I Clinical Study means, as to a specific Licensed Product, a study of such product in humans designed to satisfy the requirements of 21 C.F.R. § 312.21(a), as amended from time to time, or the corresponding regulation in jurisdictions other than the United States.

Examples of Phase I Clinical Study in a sentence

• June 30, 2017 · Initiate Neon-sponsored Phase I Clinical Study for the Licensed NeoVax Product.

• Initiation of the respective phase of the clinical study shall be deemed to be achieved after the dosing of the first patient (or, in the event of a Phase I Clinical Study, of the first healthy person) in such clinical study.

• For each Initial Indication, the Parties shall, in accordance with Section 4.3(d), conduct one or more Indication Survey Studies to assess the merit of treating such particular Indication with the Targeted AIM approach using Development Candidates for which an IND has been filed and a Phase I Clinical Study has been completed.

• December 31, 2017 · Continue to execute and evaluate patient data for Neon-sponsored Phase I Clinical Study.

• The Foundation therefore agrees that prior to the completion of a Phase I Clinical Study in respect of a Phase I Product (a “Pre-Phase I Product”) the Company may decide, at its reasonable discretion, acting in good faith and following good faith consultations with the Foundation, that upon review of the available pre-clinical and clinical data that to administer said Pre-Phase I Product to a human subject would place such subject at unacceptable risk of harm (a “Safety Decision”).

More Definitions of Phase I Clinical Study

Phase I Clinical Study means any study in humans the principal purpose of which is preliminary determination of safety in healthy individuals or patients as described under 21 C.F.R. §312.21(a) with respect to the United States, or, with respect to a jurisdiction other than the United States, a similar clinical study.

Phase I Clinical Study means the clinical investigation of an investigational new drug into humans which is designed to determine the metabolism and pharmacologic actions of the drug in humans, the side effects associated with increasing doses, and if possible, early evidence of effectiveness, as approved by applicable regulatory authorities and conducted in accordance with applicable law.

Phase I Clinical Study means a study of a Licensed Product in human subjects with the endpoint of determining initial tolerance, safety or pharmacokinetic information in single dose, single ascending dose, multiple dose and/or multiple ascending dose regimens.

Phase I Clinical Study means (a) in connection with obtaining Marketing Authorization Approval in the United States, the first Clinical Study conducted in human volunteers or patients to obtain preliminary information on a Licensed Product’s safety, tolerability, pharmacodynamic activity, pharmacokinetics, drug metabolism and mechanism of action, as well as early evidence of effectiveness if possible, as more fully defined in 21 C.F.R. § 312.21(a), as may be amended or (b) in connection with obtaining Marketing Authorization Approval in any other jurisdiction, the equivalent of any such Clinical Study in such other country or jurisdiction.

Phase I Clinical Study means a human clinical trial in any country that would satisfy the requirements of 21 CFR 312.21(a).

Phase I Clinical Study. Phase I Clinical Study shall mean a clinical study of the Product in human volunteers or patients with the endpoint of determining initial tolerance, toxicity, safety and/or pharmacokinetic information, which shall be deemed commenced when the third volunteer or patient in such study has received his or her initial dose of the Product.

Phase I Clinical Study means a Clinical Study of a Licensed Product that meets the definition of a Phase I study in the Clinical Trial Regulation EU No 536/2014 and for the United States as described in 21 C.F.R. §312.21(a), or its successor regulation, or the equivalent regulation in any other country