Phase 1/2 Clinical Trial definition

Phase 1/2 Clinical Trial means a human clinical trial of a Licensed Product that is not a Phase 1 Clinical Trial or a Phase 2 Clinical Trial, but some combination thereof.

Phase 1/2 Clinical Trial shall have the meaning set forth in Section 4.1.3.

Phase 1/2 Clinical Trial means a Phase 1 Clinical Trial that (a) is also designed to satisfy the requirements of 21 C.F.R. 312.21(b) or corresponding foreign regulations; or (b) is subsequently optimized or expanded to satisfy the requirements of 21 C.F.R. 312.21(b) or corresponding foreign regulations.

Examples of Phase 1/2 Clinical Trial in a sentence

• The Director of the Investment Management Service advised that, given market volatility and the weakness in the financial sector, full indexation was not advisable for the North American equities market at that time.

• Phase 1/2 Clinical Trial in Solid Tumors, including Colorectal Cancer (in combination with durvalumab) : D419NC00001 Since February 2016, AstraZeneca has been evaluating monalizumab in combination with durvalumab in a Phase 1/2 clinical trial with up to 381 adults with advanced solid tumor malignancies.

• Projections from the Commission services' spring forecast point to the general government deficit reaching 0.6% and 2.4% in 2011 and 2012, respectively, with real GDP growing by 4.9% in 2011 and 4.0% in 2012.

• This is the level at which our analysis is pitched, focussing on how organizing principles such as R2P can highlight the simultaneous acceptance of a norm’s content and rejection of its implementation in practice.

• Combination with Thu to Address Pharmacologic Limitations of Decitabine, Interim PK/PD from a Phase 1/2 Clinical Trial of Oral Thu-Decitabine in Sickle Cell Disease.

More Definitions of Phase 1/2 Clinical Trial

Phase 1/2 Clinical Trial means, in reference to a clinical trial of a Licensed Product, that such trial combines both a Phase 1 Clinical Trial and a Phase 2 Clinical Trial of such Licensed Product into a single protocol, where the Phase 1 Clinical Trial portion is performed first to (a) establish initial safety, tolerability, pharmacokinetic and pharmacodynamic information for the Licensed Product as a monotherapy or in combination with another agent or (b) determine the maximum tolerable dose of such Licensed Product in subjects, and the Phase 2 Clinical Trial portion is performed second to further evaluate safety and/or efficacy of such Licensed Product as a monotherapy or in combination with another agent in subjects treated with a selected dose.

Phase 1/2 Clinical Trial means a controlled clinical trial which combines a PHASE 1 CLINICAL TRIAL and a PHASE 2 CLINICAL TRIAL into a single protocol. Two sets of patients are dosed in a PHASE 1/2 CLINICAL TRIAL, the first set of patients generally being lower in number and representing “Part 1” of the trial, the second set of patients generally being higher in number and representing “Part 2” of the trial.

Phase 1/2 Clinical Trial means a Clinical Trial that combines both a Phase 1 Clinical Trial and a Phase 2 Clinical Trial into a single protocol, where the Phase 1 Clinical Trial portion is performed first to (a) establish initial safety, tolerability, pharmacokinetic and pharmacodynamic information for a product as a monotherapy or in combination with another agent or (b) determine the maximum tolerable dose of a product in subjects, and the Phase 2 Clinical Trial portion is performed second to further evaluate safety and/or efficacy of that product as a monotherapy or in combination with another agent in subjects treated with a selected dose.

Phase 1/2 Clinical Trial means a single human Clinical Trial of a Licensed Product with a protocol that combines a Phase 1 Clinical Trial with a Phase 2 Clinical Trial, regardless of whether such trial is referred to as a “phase 1/2 clinical trial” in the Development Plan.

Phase 1/2 Clinical Trial means a Clinical Trial that combines both a Phase 1 Clinical Trial and a Phase 2 Clinical Trial into a single protocol, where the Phase 1 Clinical Trial portion is performed first to (a) establish initial safety, tolerability, pharmacokinetic and pharmacodynamic information for a pharmaceutical or biological product as a monotherapy or in combination with another agent and (b) determine the maximum tolerable dose of such product, and the Phase 2 Clinical Trial portion is performed second to evaluate the safety and efficacy of such product as a monotherapy or in combination with another agent in subjects with a target disease or medical condition treated with a selected dose. For clarity, “Phase 1/2 Clinical Trial” shall include any Clinical Trial that includes any combination of the portions of a Phase 1 Clinical Trial and a Phase 2 Clinical Trial, including a Phase 1b/2a Clinical Trial or a Phase 1b/2 Clinical Trial.

Phase 1/2 Clinical Trial means the Clinical Trial with identifier NCT05788536, titled “A Study of DB-OTO, an AAV Based Gene Therapy, in Children/Infants With Hearing Loss Due to Otoferlin Mutations (CHORD).”

Phase 1/2 Clinical Trial means a human clinical trial that would satisfy the requirements for a Phase 1 study as defined in 21 C.F.R. 312.21(a) (or its successor regulation) and/or the requirements for a Phase 2 study as defined in 21 C.F.R. 312.21(b) (or its successor regulation).