Phase I Clinical Trial means a study in humans which provides for the first introduction into humans of a product, conducted in normal volunteers or patients to generate information on product safety, tolerability, pharmacological activity or pharmacokinetics, or otherwise consistent with the requirements of U.S. 21 C.F.R. §312.21(a) or its foreign equivalents.
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
Without limiting the generality of the foregoing in this Section 5.3(a), Affimed shall use Commercially Reasonable Efforts to (x) file an IND for the Combination Therapy with the FDA [***]; and (y) dose the first subject in a Phase I Clinical Trial of the Combination Therapy [***].
More Definitions of Phase I Clinical Trial
Phase I Clinical Trial means a human clinical trial normally conducted in healthy volunteers with the aim of establishing the pharmacokinetic, pharmacodynamic and early safety profile.
Phase I Clinical Trial means a Clinical Trial in any country that would satisfy the requirements of 21 CFR 312.21(a). For the avoidance of doubt, Phase I Clinical Trials include the Initial Phase I Clinical Trials.
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 a human clinical trial of a compound or product, the principal purpose of which is a determination of safety over a range of doses, as more fully defined in 21 C.F.R. §312.21(a), or its successor regulation, or the equivalent in any foreign country.
Phase I Clinical Trial means a human clinical trial conducted in accordance with Applicable Laws in any country or countries that is designed, either alone or together with one or more other human clinical trials conducted in any country or countries, to obtain sufficient data of safety, metabolism and pharmacokinetic properties and clinical pharmacology to permit Initiation of a Phase II Clinical Trial, as described in or contemplated by 21 C.F.R. § 312.21(a), as may be amended from time to time, or other Applicable Laws.
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 that is intended to initially evaluate the safety, tolerance or pharmacological or antigenic effects of a product in human subjects, or that is otherwise described in 21 CFR 312.21(a) as amended (or its successor regulation or comparable Laws in countries outside the United States).