Phase IIa Study definition

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.

AI-Powered Contracts

Draft, Review & Redline at the Speed of AI

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 clinical study 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 Study in a sentence

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.
By A▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇ Title: President & CEO MELIOR PHARMACEUTICALS II, LLC By: A▇▇▇▇▇ ▇▇▇▇▇▇ Title: President & CEO Protocol Number MP2-201 Protocol Title A Multi-center, Double Blind, Randomized, Placebo-controlled, Flexible Dose-Escalagion, Phase IIa Study of MLR-1019 in P▇▇▇▇▇▇▇▇’▇ Patients With L-DOPA Induced Dyskinesias Clinical Phase II Sponsor Melior Pharmaceuticals II, LLC Study Centers Approximately 10 sites distributed in the Bulgaria and Romania .
Sucampo shall provide Takeda with written notice of such Other Indication(s) within thirty (30) Business Days after the Phase IIa Study reports or other similarly advanced Clinical Study reports are available for such Other Indication(s).
The first dosing of a participant in the first such Phase II(a) Study or Phase II(b) Study shall not be undertaken by or on behalf of either Party until after the [**] criteria have been determined and documented for such Product Development Program.
Sucampo shall provide ▇▇▇▇▇▇ with notice of such Other Formulation(s) or Dosage(s) within […***…] after the Phase IIa Study reports or other advanced Clinical Study reports are available for such Other Formulation(s) or Dosage(s).
Subject to the terms and conditions of this Agreement, Biodexa shall be solely responsible for all costs associated with the Phase IIa Study and shall promptly reimburse Melior for all patent costs and drug maintenance costs associated with the Compound during the Term.

More Definitions of Phase IIa Study

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

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 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.

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.