Phase 2a Clinical Trial definition

Phase 2a Clinical Trial means a study of a pharmaceutical product the goal of which is to demonstrate the proof of the concept in human patients to evaluate safety and initial pharmacologic activity and/or efficacy in healthy volunteers and/or individuals who have a certain disease or condition before embarking on a Phase 2b Clinical Trial.

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Phase 2a Clinical Trial means, as to a specific pharmaceutical product, the first Clinical Trial in humans that is intended to study the safety, dosage and initial efficacy in a limited patient population and is prospectively designed to support the continued testing of the product in one or more further Phase 2A Clinical Trials or Phase 2B Clinical Trials. A Phase 2A Clinical Trial shall be deemed initiated upon the dosing of the first patient.

Phase 2a Clinical Trial means any human clinical trial conducted in the United States on a sufficient number of patients the primary purpose of which is to identify a dose or range of doses of a Product at a limited number of clinical sites, and which clinical trial meets the standards set forth at 21 CFR Section 312.21(b), or, with respect to a jurisdiction other than the United States, a similar clinical trial.

Examples of Phase 2a Clinical Trial in a sentence

Vertex may terminate this Agreement in its entirety in Vertex’s sole discretion, upon not less than sixty (60) days’ prior written notice to Alios, at any time after completion of the Phase 2a Clinical Trial in accordance with the Development Plan.
For the First Licensed Compound, the initial Development Plans through and including one Phase 2a Clinical Trial with respect thereto are attached hereto as Exhibit C and Exhibit D (as may be amended from time to time upon mutual agreement of the Parties, the “Development Plans,” including the “Development Plan — Pre-IND” and “Development Plan — Phase 1 and Phase 2a,” respectively).
Notwithstanding the foregoing, for the First Licensed Compound, such transition shall occur promptly following completion of the first Phase 2a Clinical Trial, if such Clinical Trial is conducted by SYNTA, or promptly following completion of Phase 1 Clinical Trials, if SYNTA does not conduct the first Phase 2a Clinical Trial.
RSVC shall fund and manage the research and development activities set forth in the R&D Plan, including with respect to the Phase 1 Clinical Trial and Phase 2a Clinical Trial described in the R&D Plan.
Numbers based on raise of $3.5 million) Phase 1 Clinical Trial – Anavex 2-73 $1.3 million Phase 2a Clinical Trial – Anavex 2-73 $500,000 (To be conducted simultaneously with phase 1 to test for efficacy) Forenap France (CRO) Research collaboration – Dr ▇▇▇▇ ▇▇▇▇▇, Case Case Western University Cleveland, Ohio $100,000 Research collaboration –Dr ▇▇▇▇▇▇ ▇▇▇▇▇▇▇,Universite Montpellier/ Amylgen SA France $100,000 Research collaboration – O.

More Definitions of Phase 2a Clinical Trial

Phase 2a Clinical Trial means a human clinical trial, the principal purpose of which is a determination of efficacy and safety, in the target population, at the intended clinical dose or doses, to confirm the optimal manner of use.

Phase 2a Clinical Trial means, as to a particular Licensed Compound for an Indication, a Phase 2 Clinical Trial, or the relevant portion thereof, conducted in a sufficient number of patients to generate sufficient data, if successful, to commence a Phase 2b Clinical Trial or a Phase 3 Clinical Trial of such Licensed Compound for such Indication.

Phase 2a Clinical Trial means, with respect to the United States, a clinical trial of a product that utilizes the pharmacokinetic and pharmacodynamic information obtained from one or more previously conducted Phase 1 Clinical Trial(s) and/or other Phase 2a Clinical Trial(s) in order to confirm the optimal manner of use of such product (dose and dose regimens) and to further evaluate safety and efficacy, as described under 21 C.F.R. §312.21(b), or, with respect to a jurisdiction other than the United States, an equivalent clinical trial.

Phase 2a Clinical Trial means a clinical trial generally consistent with 21 CFR §312.21(b) that is required for receipt of clearance or marketing authorization of a Licensed Product from the applicable Regulatory Authority and which is conducted to assess the optimal manner of use of such a Licensed Product (dose and dose regimens) and to better determine safety and efficacy of such a Licensed Product.

Phase 2a Clinical Trial means, pursuant to the approved R&D Plan, a randomized, double-blind, placebo-controlled Phase 2 Clinical Trial to investigate the effect of the Licensed Product on infection of healthy volunteers with RSV.

Phase 2a Clinical Trial means [***].

Phase 2a Clinical Trial means the first Phase 2 Clinical Trial of a product, the principal purpose of which is an initial evaluation of efficacy of the product.