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).
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.
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 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 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 of a Product conducted in a manor generally consistent with US regulation 21 CFR § 312.21(a), as amended (or its successor regulation), or other comparable regulation imposed by a Regulatory Agency in any country of the Territory.
Phase I Clinical Trial means the initial introduction, through clinical studies, of an investigational new drug into humans, designed to determine the metabolic and pharmacologic actions of the drug in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness, which if successful will permit the design of a well-controlled, scientifically valid Phase II Clinical Trial.
Phase I Clinical Trial means a human clinical trial, the principal purpose of which is preliminary determination of safety in healthy individuals or patients as described in 21 C.F.R. §312.21, or a similar clinical study in a country other than the United States.
Phase I Clinical Trial means a human clinical trial constituting the initial introduction of an investigational new drug into humans, as defined in 21 C.F.R §312.21(a) and as practiced according to the standards of the pharmaceutical industry.