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.

• The Subscriber shall receive notice and evidence of the digital entry of the number of the Securities owned by Subscriber reflected on the books and records of the Company and verified by the Company’s transfer agent, EQ Shareowner Services (the “Transfer Agent”), which books and records shall bear a notation that the Securities were sold in reliance upon Regulation A.

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

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

More Definitions of Phase I Clinical Study

Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is gaining evidence of the safety and tolerability of, and information regarding pharmacokinetics and potential pharmacological activity in a target patient population, as described in 21 C.F.R.§ 312.21(a) (as amended or any replacement thereof), or a similar clinical study prescribed by the NMPA or other Regulatory Authority in a country other than the United States.

Phase I Clinical Study means a human clinical study in any country conducted in accordance with good clinical practices (“GCPs”) in a small number of healthy volunteers or patients designed or intended to establish an initial safety profile, pharmacodynamics or pharmacokinetics of product, or that would otherwise satisfy the requirements of 21 CFR §312.21(a) or any successor regulation thereto or foreign equivalents.

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 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

Phase I Clinical Study means any Clinical Trial(s) the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, that would satisfy the requirement of 21 C.F.R. § 312.21(a), or its foreign equivalent, as may be amended from time to time, or any analogous Clinical Trial described or defined in Applicable Laws.