Phase 1 Trial definition

Phase 1 Trial means, with respect to a Licensed Product, a clinical trial (or — in case of a multi-phase clinical trial — those parts of a clinical trial) in line with the provisions of 21CFR312, Section 21 (a).

Phase 1 Trial means the initial clinical testing of a Product in humans (first-in-humans study) with the intention of gaining a preliminary assessment of the safety of such Product.

Phase 1 Trial means a human clinical trial conducted on a limited number of study subjects for the purpose of gaining evidence of the safety and tolerability of, and information regarding pharmacokinetics and potential pharmacological activity for, a product or compound, as described in 21 C.F.R. § 312.21(a) (including any such clinical study in any country other than the United States).

Examples of Phase 1 Trial in a sentence

• Characterization and Phase 1 Trial of a B Cell Activating Anti-CD73 Antibody for the Immunotherapy of COVID-19.

• Phase 1 Trial of Bone Marrow Sparing Intensity Modulated Radiation Therapy With Concurrent Cisplatin and Gemcitabine in Stage IB-IVA Cervical CancerL.K. Mell,1 C.C. Saenz,2 C.M. Yashar,1 M.T. McHale,2 J.P. Einck,1M.E. Wright,2 S.S. Noticewala,1 R.

• Phase 1 Trial of an RNA Interference Therapy for Acute Intermittent Porphyria.

• Live-attenuated Tetravalent Dengue Vaccine in Dengue-naïve Children, Adolescents, and Adults in Mexico City: Randomized Controlled Phase 1 Trial of Safety and Immunogenicity.

• It is acknowledged that many of the items on the List may also be applicable to other trial settings (e.g. community based health services and purpose-built Phase 1 Trial Centres).• The List has been developed with reference to stakeholders from the commercial, collaborative research/trial group, and academic sector that are involved in funding/sponsoring trials.

More Definitions of Phase 1 Trial

Phase 1 Trial means a human clinical trial in any country that would satisfy the requirements of 21 C.F.R. §312.21(a), as amended, or the comparable law in a country other than the United States.

Phase 1 Trial means a human clinical trial of a Product in any country that satisfies the requirements of 21 C.F.R. § 312.21(a), or its foreign equivalent.

Phase 1 Trial means that portion of the clinical development program that provides for closely monitored clinical trials of the product in a human population designed to determine the metabolism and pharmacologic actions of the drug in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness of the drug, as more fully defined in 21 C.F.R. § 312.21(a), or its successor regulation, or the equivalent in any foreign country.

Phase 1 Trial means, as to a specific Licensed Product, a clinical study in humans of the safety of such Licensed Product, which is prospectively designed to generate sufficient data (if successful) to commence a Phase 2 Trial (or foreign equivalent) of such product, as further defined in Federal Regulation 21 C.F.R. 312.21(a), as amended from time to time, or the corresponding regulation in jurisdictions other than the United States.

Phase 1 Trial means a human clinical trial of a Product, the principal purpose of which is a preliminary determination of safety in patients or healthy individuals, or the metabolism and pharmacokinetic properties and clinical pharmacology of such Product, and generally consistent with 21 C.F.R. § 312.21(a).

Phase 1 Trial means the first clinical study of the applicable Development Candidate in human beings Initiated by Biogen, its Affiliate or its Sublicensee.

Phase 1 Trial means that portion of the clinical development program that generally provides for the first introduction into humans of a product with the primary purpose of determining safety, metabolism and pharmacokinetic properties and clinical pharmacology of the