Phase 2a Clinical Trial definition

Phase 2a Clinical Trial means a study of a pharmaceutical product the goal of which is to demonstrate the proof of the concept in human patients to evaluate safety and initial pharmacologic activity and/or efficacy in healthy volunteers and/or individuals who have a certain disease or condition before embarking on a Phase 2b Clinical Trial. *Confidential Treatment Requested

Phase 2a Clinical Trial means, as to a specific pharmaceutical product, the first Clinical Trial in humans that is intended to study the safety, dosage and initial efficacy in a limited patient population and is prospectively designed to support the continued testing of the product in one or more further Phase 2A Clinical Trials or Phase 2B Clinical Trials. A Phase 2A Clinical Trial shall be deemed initiated upon the dosing of the first patient.

Phase 2a Clinical Trial means a human clinical trial, the principal purpose of which is a determination of efficacy and safety, in the target population, at the intended clinical dose or doses, to confirm the optimal manner of use.

Examples of Phase 2a Clinical Trial in a sentence

• Phase 2a Clinical Trial On August 3, 2022 the Company engaged hVIVO, a subsidiary of London-based Open Orphan plc (AIM: ORPH), a rapidly growing specialist contract research organization (CRO), to conduct a Phase 2a clinical trial with the Company’s novel, broad-spectrum, orally administered antiviral influenza candidate.

• Nanchahal J, Ball C, Davidson D, Williams L, Sones W, McCann FE, Cabrita M, Swettenham J, Cahoon NJ, Copsey B, Anne Francis E, Taylor PC, Black J, Barber VS, Dutton S, Feldmann M, Lamb SE: Anti-Tumour Necrosis Factor Therapy for Dupuytren's Disease: A Randomised Dose Response Proof of Concept Phase 2a Clinical Trial.

• First Phase 2a Clinical Trial Topline Results In December 2015, we reported supportive topline results from our Phase 2a clinical trial of SYN-004 (ribaxamase), including data from ten ileostomized participants that demonstrated SYN-004 (ribaxamase) successfully degraded residual IV ceftriaxone in the chyme (digestive fluid in the small intestine) without affecting the intended level of ceftriaxone in the bloodstream.

• Many thanks!!!Tim GougerUSACE-AED (TAN-BGR)I received 2 boxes today from Omaha.

• If Phase 2 or Phase 2a Clinical Trial is sufficient for Approval Application in U.S., Submission of Approval Application in U.S.

More Definitions of Phase 2a Clinical Trial

Phase 2a Clinical Trial means a pilot Phase 2 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 pharmaceutical product and other characteristics of safety and efficacy.

Phase 2a Clinical Trial means, with respect to the United States, a clinical trial of a product that utilizes the pharmacokinetic and pharmacodynamic information obtained from one or more previously conducted Phase 1 Clinical Trial(s) and/or other Phase 2a Clinical Trial(s) in order to confirm the optimal manner of use of such product (dose and dose regimens) and to further evaluate safety and efficacy, as described under 21 C.F.R. §312.21(b), or, with respect to a jurisdiction other than the United States, an equivalent clinical trial.

Phase 2a Clinical Trial means, as to a particular Licensed Compound for an Indication, a Phase 2 Clinical Trial, or the relevant portion thereof, conducted in a sufficient number of patients to generate sufficient data, if successful, to commence a Phase 2b Clinical Trial or a Phase 3 Clinical Trial of such Licensed Compound for such Indication.

Phase 2a Clinical Trial means a clinical trial generally consistent with 21 CFR §312.21(b) that is required for receipt of clearance or marketing authorization of a Licensed Product from the applicable Regulatory Authority and which is conducted to assess the optimal manner of use of such a Licensed Product (dose and dose regimens) and to better determine safety and efficacy of such a Licensed Product.

Phase 2a Clinical Trial means any human clinical trial conducted in the United States on a sufficient number of patients the primary purpose of which is to identify a dose or range of doses of a Product at a limited number of clinical sites, and which clinical trial meets the standards set forth at 21 CFR Section 312.21(b), or, with respect to a jurisdiction other than the United States, a similar clinical trial.

Phase 2a Clinical Trial means a Phase 2 Clinical Trial of a pharmaceutical product, the principal purpose of which is to establish a dose range, appropriate combinations, and further safety and tolerability over a longer duration of dosing, and initial efficacy.

Phase 2a Clinical Trial means a Phase 2 Clinical Trial designed to demonstrate feasibility of a product for an indication.