Phase I Study definition

Phase I Study means a human clinical trial in any country that would satisfy the requirements of 21 C.F.R. § 312.21(a) (FDCA), as amended from time to time, and the foreign equivalent thereof.

Phase I Study means a study in humans which provides for the first introduction into humans of a product, conducted in healthy volunteers or patients to obtain information on product safety, tolerability, pharmacological activity or pharmacokinetics, as more fully defined in 21 C.F.R. § 312.21(a) (or the non-United States equivalent thereof).

Phase I Study means a clinical study of an Alnylam Royalty Product in human volunteers or patients the purpose of which is preliminary determination of safety and tolerability of a dosing regime and for which there are no primary endpoints (as understood by the FDA or other Regulatory Authorities) in the protocol relating to efficacy.

Examples of Phase I Study in a sentence

• Assessment of EGFR Mutation Status in Matched Plasma and Tumor Tissue of NSCLC Patients from a Phase I Study of Rociletinib (CO-1686).

• Senate Concurrent Resolution 39 response: Phase I Study – Exploring the Reorganization of Levee Districts and Other State-Created Entities with Flood Control Responsibilities.

• Multimodal Corridor Project Status: The I-290 Preliminary Engineering and Environmental (Phase I) Study started from a clean slate in Fall of 2009.

• The reports submitted by the consultant shall be accepted by SEC after approved by the POEs. Phase I Study The feasibility study shall be updated in considerations of the project as a regional project of multipurpose nature with storage for irrigation, electricity generation, flood mitigations, etc.

• Results of Phase I Study of CC-5013 for the Treatment of Multiple Myeloma (MM) Patients Who Relapse after High Dose Chemotherapy (HDCT).

More Definitions of Phase I Study

Phase I Study means a study of a Licensed Product in humans, the principal purpose of which is a determination of safety, tolerability or pharmacokinetics in healthy individuals or patients in the target patient population prescribed by the relevant Regulatory Authority, from time to time, pursuant to applicable law or otherwise, including the trials referred to in 21 C.F.R. §312.21(a), as amended.

Phase I Study means a Phase I clinical trial as prescribed by applicable FDA regulations, or corresponding regulations of any comparable entity.

Phase I Study means: (a) that portion of the FDA submission and approval process which provides for the first introduction into humans of a product with the purpose of determining human toxicity, metabolism, absorption, elimination and other pharmacological action, as more fully defined by the rules and regulations of the FDA, including 21 C.F.R. § 312.21(a) or any future revisions or substitutes therefor; or (b) a similar clinical trial in any national jurisdiction other than the United States. For the avoidance of doubt, the emphasis of a PHASE I STUDY is on the safety and tolerability of a product and is used to plan patient dosing in a PHASE II STUDY.

Phase I Study means a clinical study in subjects to evaluate the pharmacokinetic and pharmacodynamic properties, maximum tolerated dose, dosing interval, and absorption, distribution, metabolism and excretion (ADME) of a Licensed Product.

Phase I Study means a clinical trial of a Product generally consistent with 21 CFR §312.21(a) or equivalent trial outside of the United States.

Phase I Study means the clinical study regarding AZD 1419 with the design, endpoint, number of subjects and time plan described, and otherwise as described, in the Amendment Development Phase I Study Plan, attached hereto as a Schedule 2.

Phase I Study means a human clinical trial of a product containing the Compound, the principal purpose of which is a preliminary determination of safety or pharmacokinetics in healthy individuals or patients or similar clinical study prescribed by the Regulatory Authorities, from time to time, pursuant to Applicable Law or otherwise.