Phase I Clinical Trial definition
Phase I Clinical TrialÌýmeans a human clinical trial with a principal purpose of preliminarily determining the safety of a pharmaceutical product in healthy individuals or patients as required in 21 C.F.R. §312.21(a), or similar clinical study in a country other than the United States, and for which there are no primary endpoints related to efficacy.
Phase I Clinical TrialÌýmeans a controlled human clinical study that would satisfy the requirements of 21 CFR 312.21(a), designed to provide evidence of safety and tolerability, metabolism, and pharmacological activity, the adverse experiences associated with increasing doses, and, possibly, early evidence of efficacy of a Compound. Any clinical study in healthy volunteers is a Phase I Clinical Study.
Phase I Clinical TrialÌýmeans the first study of a Product in humans the primary purpose of which is the determination of safety and which may include the determination of pharmacokinetic and/or pharmacodynamic profiles in healthy individuals or patients.
Examples of Phase I Clinical Trial in a sentence
The Parties shall negotiate and, within [***] of the Effective Date, enter into a separate agreement for the supply of Licensed Compounds and Licensed Products to ArriVent by Lepu’s contract manufacturer for use by ArriVent in the first Phase I Clinical Trial in the ArriVent Territory.
The Parties may negotiate and enter into a separate agreement for the supply of Licensed Compounds and Licensed Products to ArriVent by Lepu’s contract manufacturer for studies in the ArriVent Territory after the first Phase I Clinical Trial.
More Definitions of Phase I Clinical Trial
Phase I Clinical TrialÌýmeans a human clinical trial in any country that would satisfy the requirements of 21 CFR 312.21(a).
Phase I Clinical TrialÌýmeans 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 TrialÌýmeans 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 TrialÌýmeans a human clinical trial that satisfies the requirements of 21 C.F.R. § 312.21(a).
Phase I Clinical TrialÌýmeans 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 TrialÌýmeans 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 TrialÌýmeans a clinical trial of a Licensed Product in human patients at single and multiple dose levels with the primary purpose of determining safety, metabolism, and pharmacokinetic and pharmacodynamic properties of such Licensed Product, and which is consistent with 21 U.S. CFR § 312.21(a). For the avoidance of doubt, a Phase I Clinical Trial may include studies of the Licensed Compounds with chemotherapy agents to determine combination doses thereof.