Phase 1/2 Study definition

Phase 1/2 Study means a clinical study of a drug candidate in diseased human patients that satisfies the requirements of a Phase 1 Study and a Phase 2 Study.
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Phase 1/2 Study means a human clinical trial of a compound, the initial principal purpose of which is to determine preliminary safety in a target patient population followed by a Phase 2 Study component, the principal purpose of which is to determine both efficacy and safety in the target patient population.
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Phase 1/2 Study means a combined Phase 1 Study and Phase 2 Study.
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Examples of Phase 1/2 Study in a sentence

  • For clarity, a Pivotal Study may be a Phase 2 Study, a Phase 1/2 Study, or a Phase 3 Study.

  • Arrowhead shall only be authorized to use such data and information to the extent required for the conduct of the Ongoing Phase 1/2 Study and nothing in this Exhibit H is intended to transfer ownership of such data and information.

  • Arrowhead shall use Commercially Reasonable Efforts to conduct and complete the Ongoing Phase 1/2 Study in accordance with the Clinical Plan and to assist ▇▇▇▇▇▇▇, at no additional cost for ▇▇▇▇▇▇▇, in finalizing a Development Plan to the extent requested by ▇▇▇▇▇▇▇.

  • Arrowhead shall own all Regulatory Filings, including any IND, filed by or on behalf of Arrowhead for any Licensed Product and all regulatory approvals and authorizations resulting from such Filings, until completion or termination of the Ongoing Phase 1/2 Study.

  • Upon completion or termination of the Ongoing Phase 1/2 Study, Arrowhead will assign ownership of all Regulatory Filings, including any IND, for any License Product and all regulatory approvals and authorizations resulting from such Filings to ▇▇▇▇▇▇▇.

  • As reasonably requested by GSK and as is necessary to support the Development or obtaining Regulatory Approvals for any Licensed Product, Arrowhead shall make available to GSK and shall permit GSK to make copies at GSK’s expense the Arrowhead Know-How recorded in any form (including laboratory notebook entries, database entries, monographs, reports, and slide presentations), including all clinical data resulting from the Ongoing Phase 1/2 Study (as defined in the Original Agreement).

  • In the event Arrowhead desires to publish the results of the Ongoing Phase 1/2 Study, Arrowhead shall provide ▇▇▇▇▇▇▇ at least [**] to review and approve such publication prior to submission of such publication.

  • Arrowhead shall, at its sole cost and expense, be responsible for the conduct and completion of the Ongoing Phase 1/2 Study.

  • Arrowhead shall promptly make available to ▇▇▇▇▇▇▇ and shall permit ▇▇▇▇▇▇▇ to make copies at ▇▇▇▇▇▇▇’▇ expense of all Arrowhead Know-How, including all clinical data resulting from the Ongoing Phase 1/2 Study, which becomes available following the Effective Date.

  • Subject to the terms and conditions of this Agreement, Sutro hereby grants to BioNova and its Affiliates an exclusive (even with respect to Sutro and its Affiliates), sublicensable (to Affiliates only, subject to Section 3.2(a)), non-transferable (except as provided in Section 16.1), royalty-free license under the Licensed Technology to Develop and otherwise use, distribute, and import the Licensed Products in the Field in the Territory solely to conduct the Phase 1/2 Study in the Territory.


More Definitions of Phase 1/2 Study

Phase 1/2 Study means, with respect to a Product, a first Clinical Study in humans of such Product, as further defined in 21 C.F.R. § 312.21(a) or the corresponding regulation in jurisdictions other than the United States.
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Phase 1/2 Study means a Clinical Study of the Licensed Product conducted by or on behalf of BioNova or its Affiliates in the Territory, as illustrated in the study design and development plan described in Exhibit E.
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Phase 1/2 Study means a Clinical Study that is designed to satisfy the requirements of 21 C.F.R. 312.21(a) or corresponding foreign regulations and is subsequently optimized or expanded to satisfy the requirements of 21 C.F.R. 312.21(b) (or corresponding foreign regulations).
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Phase 1/2 Study means a human clinical trial (or any arm thereof) of a pharmaceutical or biologic product with the endpoint of (a) determining initial tolerance, safety, metabolism, pharmacokinetic or pharmacodynamic information in single dose, single ascending dose, multiple dose, or multiple ascending dose regimens, and (b) evaluating its effectiveness for a particular indication or indications in one or more specified doses or its short term tolerance and safety, as well as its pharmacokinetic and pharmacodynamic information in patients with the indications under study, that is prospectively designed to generate sufficient data (if successful) to commence a Phase 3 Study for such product (the endpoint in this Section 1.82(b) being referred to as the “Efficacy Endpoint”), and that satisfies the requirements of U.S. federal regulation 21 C.F.R. §§ 312.21(a) and (b) and its successor regulation or equivalents in other jurisdictions.
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Related to Phase 1/2 Study

  • Phase 3 Study means a clinical study of a drug candidate in human patients that incorporates accepted endpoints for confirmation of statistical significance of efficacy and safety with the aim to obtain Regulatory Approval in any country as described in 21 C.F.R. 312.21(c), or a comparable clinical study prescribed by the relevant Regulatory Authority in a country other than the United States. The relevant drug candidate may be administered to patients as a single agent or in combination with other investigational or marketed agents.

  • 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 2 Trial means a human clinical trial conducted on study subjects with the disease or condition being studied for the principal purpose of achieving a preliminary determination of efficacy or appropriate dosage ranges, as further described in 21 C.F.R. §312.21(b) (including any such clinical study in any country other than the United States).

  • Phase III Study means a human clinical trial that is prospectively designed to demonstrate statistically whether a product is safe and effective for use in humans in a manner sufficient to obtain regulatory approval to market such product in patients having the disease or condition being studied as described in 21 C.F.R. § 312.21(c) (FDCA), as amended from time to time, and the foreign equivalent thereof.

  • Phase II Study means a human clinical trial, for which the primary endpoints include a determination of dose ranges and/or a preliminary determination of efficacy in patients being studied as described in 21 C.F.R. § 312.21(b) (FDCA), as amended from time to time, and the foreign equivalent thereof.