Phase I Clinical Trial definition

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 I Clinical Trial means a human clinical trial in any country that would satisfy the requirements of 21 CFR 312.21(a), as may be amended, or the foreign equivalent thereof.
Phase I Clinical Trial means a human clinical trial in any country that would satisfy the requirements of 21 CFR 312.21(a).

Examples of Phase I Clinical Trial in a sentence

  • The Sponsor must provide any ongoing safety and toxicology data updates to the Principal Investigator immediately, to ensure the safety of the Clinical Trial Subjects in this Phase I Clinical Trial.

  • The [Sponsor][CRO] (delete as appropriate) must provide any ongoing safety and toxicology data updates to the Principal Investigator immediately, to ensure the safety of the Clinical Trial Subjects in this Phase I Clinical Trial.

  • Notwithstanding the foregoing, if Merck shall at any time commence a Phase I Clinical Trial on a Compound without having formally exercised its Development Election, Merck shall be deemed to have exercised its Development Election with respect to such Compound.

  • The Project Liaisons shall be the primary contact between the Parties with respect to the Research Programs as well as with respect to subsequent Development activities hereunder until the Initiation of the first Phase I Clinical Trial with respect to a Product.

  • If GSK exercises the Inhaled Option or Liquidia Respiratory Option, then GSK and Liquidia shall enter into a written pharmacovigilance agreement prior to GSK commencing the first Phase I Clinical Trial with the Liquidia Respiratory Product or the first Research Product, as the case may be, setting forth mutually acceptable guidelines and procedures for the receipt, investigation, recordation, and communication of adverse events and safety data that relate to the PRINT Material.


More Definitions of Phase I Clinical Trial

Phase I Clinical Trial means the initial introduction of a Licensed Product as an investigational new drug into humans as required in 21 C.F.R. § 312, designed to determine the metabolism and pharmacologic actions of the Licensed Product in humans, the side effects associated with increasing doses and, if possible, to gain early evidence on effectiveness, and also includes studies of drug metabolism, structure-activity relationships and mechanism of action in humans.
Phase I Clinical Trial means a clinical trial of a Product generally consistent with 21 C.F.R. § 312.21(a) (or the non-United States equivalent thereof).
Phase I Clinical Trial means the initial clinical testing of the Product in humans (first-in-humans study) with the intention of gaining a preliminary assessment of the safety of the Product.
Phase I Clinical Trial means a human clinical trial in any country conducted by Company or its Affiliate to initially evaluate the safety of a Licensed Product in human subjects or that would otherwise satisfy the requirements of 21 CFR 312.21 (a) or the equivalent laws, rules or regulations in a regulatory jurisdiction outside the United States.
Phase I Clinical Trial means any clinical study conducted on sufficient numbers of human subjects to establish that a pharmaceutical product is reasonably safe for continued testing and to support its continued testing in Phase II Clinical Trials as required by 21 C.F.R. § 312.21(a) or similar Applicable Law in a country other than the United States.
Phase I Clinical Trial means a human clinical trial normally conducted in healthy volunteers or diseased patients with the aim of determining the pharmacokinetics, pharmacodynamics, early safety profile and some preliminary evidence of efficacy if conducted in patients. Phase I Clinical Trials in Oncology Indications [***]. For the avoidance of doubt, a Phase I Clinical Trial does not include studies where the [***]. Any trial with [***].
Phase I Clinical Trial means a human clinical trial, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients as required in 21 C.F.R. §312, or a similar clinical study prescribed by the regulatory authorities in a country other than the United States.