Phase II Clinical Trial

Phase II Clinical Trial. Shall mean a human clinical trial in any country that is intended to initially evaluate the effectiveness of a Product for a particular indication or indications in patients with the disease or indication under study or that would otherwise satisfy requirements of 21 CFR 312.21(b), or its foreign equivalent.

Phase II Clinical Trial. Means, with respect to the United States, well-controlled clinical trials in human subjects, including clinical trials conducted in patients with a condition, and designed to evaluate clinical activity (including but not limited to, pertinent pharmacodynamic effects or biomarker * Confidential treatment requested; certain information omitted and filed separately with the SEC. 4 responses) and safety for a Licensed Product for one or more indications, as well as to obtain an... indication of the dosage regimen required, as more fully defined in 21 C.F.R. § 312.21(b), as may be amended, and, with respect to any other country or jurisdiction, the equivalent of such a clinical trial in such other country or jurisdiction. View More

Phase II Clinical Trial. Means a human clinical trial in any country conducted to evaluate the effectiveness of a therapeutic product, for a particular indication or indications in patients with the disease or condition under study and, possibly, to determine the common short-term side effects and risks associated with the therapeutic product. In the United States, "Phase II Clinical Trial" means a human clinical trial that satisfies the requirements of 21 C.F.R. § 312.21 (b).

Phase II Clinical Trial. Means a human clinical trial that is intended to initially evaluate the effectiveness of a Licensed Product in the targeted patient population for a particular indication or indications in human subjects with the disease or indication under study, as more fully defined in 21 C.F.R. 312.21(b).

Phase II Clinical Trial. Means, with respect to a clinical trial conducted pursuant to an IND, any controlled human clinical trial conducted in the United States as required under and pursuant to 21 C.F.R. §312.21(b) and subject to the general oversight of the FDA, or, with respect to a jurisdiction other than the United States, a similar clinical study subject to the general oversight of the applicable Regulatory Authority.

Phase II Clinical Trial. Any human clinical trial of a Licensed Product conducted for purposes of preliminary determination of efficacy and/or preliminary establishment of appropriate dosage ranges for efficacy and safety in patients, as described under 21 C.F.R. §312.21(b) (as hereafter modified or amended) and any of its foreign equivalents

Phase II Clinical Trial. As to a particular product for a particular indication, the initial controlled and lawful study in humans of the safety, dose ranging and efficacy of such product for such indication, which is prospectively designed to generate data to support commencing a Phase III Clinical Trial of such product for such indication.

Phase II Clinical Trial. Shall have the meaning ascribed by the FDA and as promulgated under 21 C.F.R. § 312.21(b).

Phase II Clinical Trial. The term "Phase II Clinical Trial" shall mean those further and lawful studies of a Product conducted anywhere in the Territory that the applicable Regulatory Authority requires to be performed on a sufficient number of human patients with the condition treated by the Product to generate sufficient data to establish the safety, and biological activity of that Product for its intended use and to permit commencement of a Phase III Clinical Trial.

Phase II Clinical Trial. Means a human clinical trial of a Licensed Product that satisfies the requirements of 21 CFR 312.21(b).