Phase IIa Trial definition

Phase IIa Trial means a small scale Phase II Trial intended principally to demonstrate the proof of concept of a pharmaceutical product in humans to determine whether (and in what manner) to pursue Regulatory Approval of such product.

Phase IIa Trial means a pilot Phase II Clinical Trial in the relevant human patient population for the purpose of determining the safe and effective dose range for the proposed therapeutic indication of a product and other characteristics of safety and efficacy, as exemplified in 21 C.F.R. § 312.21(b).

Phase IIa Trial means any controlled clinical study involving the use of a Product in patients that is designed primarily to obtain preliminary data on the effectiveness of a specific therapy involving the use of a Product in patients;

Examples of Phase IIa Trial in a sentence

• Brief Report: A Prospective Open-Label Phase IIa Trial of Tocilizumab in the Treatment of Polymyalgia Rheumatica.

• A Phase IIa Trial is a Phase II Trial that is a human clinical trial in not less than 70 patients with the disease or indication under study and that is designed to provide an indication of the efficacy of the Licensed Product for its intended use, and a Phase IIb Trial is a Phase II Trial in patients with the disease or indication under study that is a well-controlled trial designed to be statistically significant.

• Phase IIa Trial of Chimeric Antigen Receptor Modified T Cells Directed Against CD19 (CTL019) in Patients with Relapsed or Refractory CD19+ Lymphomas.

• La Jolla will use commercially reasonable efforts to implement and conduct all development, manufacturing and regulatory activities required in order to complete the Phase IIa Trial.

• Abstract 1222 - Phase IIa Trial of Imatinib Mesylate (Gleevec) in the Treatment of Diffuse Systemic Sclerosis - An Interim Analysis In. ACR; 2008.

More Definitions of Phase IIa Trial

Phase IIa Trial means any controlled clinical study involving the use of the Licensed Product in human patients that

Phase IIa Trial means a Phase II Trial in a pilot form.

Phase IIa Trial means the first controlled clinical study measuring the efficacy of any Product.

Phase IIa Trial means any controlled clinical study involving the use of the Licensed

Phase IIa Trial means any controlled clinical study involving the use of the Licensed Product in human patients that is designed primarily to obtain preliminary data on the effectiveness of a specific therapy involving the use of a Licensed Product in human patients. Phase IIa Trials must take place after Phase I Trials. 1.30 "Pivotal Trial" shall mean any Phase IIb/III clinical study involving a Licensed Product and having adequate statistical power to meet the requirements for regulatory approval by the FDA or the European Commission. 1.31 "Recognised Agents" shall mean any third party legal entity (other than an Affiliate of BI) engaged by BI in the normal course of its business to market and/or distribute its products in a particular country of the Territory. 1.32 "Sublicensee" shall mean any person, corporation, unincorporated body, or other entity including Affiliates of BI to whom BI grants a sublicense of the rights granted to BI pursuant to this Agreement. For the avoidance of doubt, Recognised Agents shall not be considered to be Sublicensees for the purposes of this Agreement. 1.33 "Target Antigen" shall mean either [ * ] and its [ * ] or, in case Section [ * ] applies, [ * ]

Phase IIa Trial means a Clinical Trial of the Product in patients with a specific tumor type to evaluate safety and preliminary evidence of efficacy, but is not designed to determine an optimal dose of the product.

Phase IIa Trial. “Phase IIb Trial” and “Phase III Trial” shall have the following meanings: