Phase IIa Clinical Trial definition

Phase IIa Clinical Trial means a relatively small Phase II Clinical Study designed to study the effectiveness of a particular Product against placebo or other positive controls for a particular indication in patients with the disease or condition under study, including narrowing the optimal dose, the potential utility, and common short-term side effects of the Product.

Phase IIa Clinical Trial means a Phase II Clinical Trial that is solely intended to make a preliminary determination of the effectiveness of a Product for a particular indication or indications in patients with the disease or indication under study.

Phase IIa Clinical Trial means a Phase II Clinical Trial intended for dose exploration, dose response, duration of effect, kinetic/dynamic relationship and preliminary efficacy and safety study of a candidate drug in the target patient population.

Examples of Phase IIa Clinical Trial in a sentence

• This work includes, but is not limited to, working with the FDA to better understand and refine the next steps in development of the product.On August 13, 2014, the Company announced that the preliminary results of its Phase IIa Clinical Trial, TARDOXALTM for the Treatment of Tardive Dyskinesia (TEND-TD) showed a non-statistically significant improvement in the primary efficacy endpoint in patients treated with TARDOXALTM.

• TARDOXALTM's potential for treatment of TD is supported by its biological mechanism of action and by preliminary clinical studies which indicated efficacy of a related compound in treatment of TD.On August 13, 2014, the Company announced that the preliminary results of its Phase IIa Clinical Trial, TARDOXALTM for the Treatment of Tardive Dyskinesia (TEND-TD) showed a non-statistically significant improvement in the primary efficacy endpoint in patients treated with TARDOXALTM.

• BI shall work towards [***] during the course of the Phase I Clinical Trial and Phase IIa Clinical Trial.

• Without limitation on its other rights under this Agreement, BI shall review the anticipated cost of goods of Product(s) at the time that the Phase IIa Clinical Trial data for the Product(s) becomes available, and shall notify Zealand Pharma if BI determines that it is likely to terminate further development of the Product(s) and reply to Zealand Pharma’s reasonable requests for information concerning the formulations and manufacturing procedures considered by BI.

• Without limitation on its other rights under this Agreement, BI shall review [***] at the time that the Phase IIa Clinical Trial data for the Product(s) becomes available, and shall notify Zealand Pharma if BI determines that it is likely to terminate further development of the Product(s) and reply to Zealand Pharma’s reasonable requests for information concerning the formulations and manufacturing procedures considered by BI.

More Definitions of Phase IIa Clinical Trial

Phase IIa Clinical Trial means, with respect to a Royalty-Bearing Product, any human clinical trial conducted in patients with a particular Indication for the purpose of studying the pharmacokinetic or pharmacodynamic properties and preliminary assessment of safety and efficacy of such Royalty-Bearing Product over a measured dose response, as described in 21 C.F.R. §312.21(b) or its foreign counterpart.

Phase IIa Clinical Trial means a Phase II Clinical Trial of a Licensed Product designed to assess dosing, safety and pharmacodynamic activity in at least one (1) target patient population.

Phase IIa Clinical Trial means an initial Phase II Clinical Trial in any therapeutic Indication that is designed to evaluate safety and to demonstrate a meaningful trend of efficacy in patients who have the disease or condition that the Compound is intended to treat.

Phase IIa Clinical Trial means that portion of the clinical development program which provides for the initial trials of a Collaboration product on a limited number of patients for the purpose of determining whether the Collaboration Product affects a surrogate marker or indicator of pharmacological or clinical activity in the proposed therapeutic indication, as more fully described in 21 C.F.R. § 312.21(b), or its successor regulation, or the equivalent in any foreign country.

Phase IIa Clinical Trial means a dose exploration, dose response, duration of effect, kinetic/dynamic relationship and/or preliminary efficacy and safety study of a VEGF Product in the target patient population.

Phase IIa Clinical Trial human clinical trial where Product is tested in a limited number of patients for the purpose of establishing a first indication of efficacy of Product a New Indication.

Phase IIa Clinical Trial means a Phase II Clinical Trial whose primary objective is to explore safety and tolerability, pharmacokinetic and pharmacodynamic effects in human patients in a study [*]. “Phase IIb Clinical Trial” shall mean a clinical trial that is initiated after the release of data concerning a completed Phase I Clinical Trial and which has the primary objective to collect data on dosages and additional data on safety, and make an initial demonstration of clinical efficacy in a target population for a specific disease or condition under study. In a Phase IIb Clinical Trial, the trial results are to be assessed for statistically significant differences between groups for clinical endpoints considered as a basis for registration, which may include generally accepted surrogate pharmacodynamic endpoints. [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.