Phase IIa Study definition

Phase IIa Study means a controlled study conducted in patients with the disease or condition designed to evaluate clinical efficacy and safety for such Alliance Product for one or more indications using generally accepted primary clinical endpoint(s). For the avoidance of doubt, a Phase IIa Study shall not be a study designed [*].

Phase IIa Study means a human clinical trial of a product containing the Compound, the principal purpose of which is a demonstration of proof of concept in the target patient population or a similar clinical study prescribed by the Regulatory Authorities, from time to time, pursuant to Applicable Law or otherwise.

Phase IIa Study means a dose exploration or dose response study that may also include evaluation of safety and efficacy of the Licensed Product in the patient population or a controlled dose ranging clinical study to define the optimal dosing regimen.

Examples of Phase IIa Study in a sentence

• A Phase IIa Study to Assess the Safety, Efficacy, and Pharmacokinetics of Subcutaneously Administered APL-2 in Subjects With PNH.

• After the Option Trigger Date, Pfizer shall have the right from time to time to request additional efficacy and safety data from both the Phase Ib Study and the Phase IIa Study that was generated during the Option Period, and Lpath shall provide such information *** after such request.

• It would lead to a Phase IIa Study with the same 50mg/day dose as I have discussed above.

• A Randomized, Double-Blind, Placebo-Controlled Phase IIa Study of Quintuple Therapy to Treat COVID-19 Infection.

• Eser A, Colombel JF, Rutgeerts P, Vermeire S, Vogelsang H, Braddock M, Persson T, Reinisch W (2015) Safety and Efficacy of an Oral Inhibitor of the Purinergic Receptor P2X7 in Adult Patients with Moderately to Severely Active Crohn's Disease: A Randomized Placebo-controlled, Double-blind, Phase IIa Study.

More Definitions of Phase IIa Study

Phase IIa Study shall have the meaning set forth in Section 1.46.

Phase IIa Study means a human clinical trial of a product, the principal purpose of which is a demonstration of proof of concept in the target patient population or a similar clinical study prescribed by the Regulatory Authorities, from time to time, pursuant to Applicable Law or otherwise.

Phase IIa Study means a preliminary efficacy and safety study of a Collaboration Product or Licensed Product in the target patient population designed to demonstrate clinical proof of concept.

Phase IIa Study. Phase II(a) Study shall mean a preliminary efficacy and safety study of an siRNA or Product in the target patient population designed to demonstrate Clinical Proof of Concept.

Phase IIa Study means, with respect to the United States, any human clinical trial conducted in patients with the disease or condition of interest for the purpose of studying the pharmacokinetic or pharmacodynamic properties and preliminary assessment of safety of the drug being studied over a measured dose response as described under 21 C.F.R. § 312.21(b), or, with respect to a jurisdiction other than the United States, a similar clinical study.

Phase IIa Study. Phase IIA Study means a 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.

Phase IIa Study means a statistically significant preliminary efficacy and safety study of a Selected Combination Product or Selected Licensed Product in the target patient population designed to demonstrate clinical proof-of-concept.