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

• 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.

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

• A Phase IIa Trial of Sorafenib with Capecitabine and Oxaliplatin in Patients with Locally Advanced or Metastatic Hepatocellular Carcinoma A Phase III randomized, double-blind, placebo-controlled study of sorafenib as adjuvant treatment for hepatocellular carcinoma after surgical resection or local ablation27.

• A Randomized, Placebo-Controlled Phase IIa Trial to Evaluate the Biological Activity, Safety, and Tolerability of Autologous Regulatory T Lymphocytes (Tregs) Expanded Ex-Vivo and Returned Intravenously in Combination with Low-Dose IL-2 in People with Amyotrophic Lateral Sclerosis (ALS) (ALS Ph2a Treg Study).

• Title: A Randomized, Placebo-Controlled Phase IIa Trial to Evaluate the Biological Activity, Safety, and Tolerability of Autologous Regulatory T Lymphocytes (Tregs) Expanded Ex-Vivo and Returned Intravenously in Combination with Low-Dose IL-2 in People with Amyotrophic Lateral Sclerosis (ALS) Study Description: Increasing evidence demonstrates that dysregulation of theimmune system hastens ALS disease progression.

More Definitions of Phase IIa Trial

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

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

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

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

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.