Phase Ib Clinical Trial definition

Phase Ib Clinical Trial means the cohort expansion phase of a Phase I Clinical Trial of a Therapeutic Product after the Dose Escalation Study portion of such Phase I Clinical Trial that includes the dosing of one or more cohorts of patients at the recommended dose determined in such Dose Escalation Study, the principal purpose of which cohort expansion phase is to evaluate safety, tolerability and indication of efficacy of such Therapeutic Product in patients, and which cohort expansion phase would generally be considered a phase Ib Clinical Trial in the oncology field in the United States.

Phase Ib Clinical Trial means a human clinical trial, the principal purpose of which is to determine the recommended phase 2 dose involving cohort expansion at one or more dose levels. The recommended phase 2 dose, which may differ from the MTD, will be determined on the basis of results from safety, activity, and pharmacologic and correlative studies. In contrast the phase IA clinical trial involves dose escalation to determine the maximum tolerated dose (MTD). The MTD will be determined on the basis of the results from the safety evaluation.

Phase Ib Clinical Trial means an initial repeated dose, dose escalation Phase I Clinical Trial conducted in a small number of patients infected with the hepatitis C virus (HCV) to establish the safety profile of the Compound and to collect additional data on its pharmacokinetics and pharmacological effects, including antiviral activity.

Examples of Phase Ib Clinical Trial in a sentence

• Each Development Plan will set out activities required for the development of the relevant Compound through to the completion of the first Phase Ib Clinical Trial of such and, subject to the Parties entering into a clinical combination agreement, the Development Plan in respect of the [***] Compound, will also provide for at least one arm of the first Phase 1b Clinical Trial to be the combination of the [***].

• Subject to Section 3.4 below, should the Parties not enter into a clinical combination agreement despite the use of good faith reasonable best efforts to agree on such terms, then the [***] Phase I Clinical Trial or Phase Ib Clinical Trial and/or the [***] Phase I Clinical Trial or Phase Ib Clinical Trial could be as a monotherapy or combination with another therapeutic agent.

• A macroinvertebrate assessment of Ozark streams located in lead-zinc mining areas of the Viburnum Trend, in southeastern Missouri, USA.

• First dosing of the first Compound in a patient in a Phase Ib Clinical Trial in the VERTEX Territory US $ 4,000,000 2.

• First dosing of the first Compound in a patient in a Phase Ib Clinical Trial in the VERTEX Territory US $4,000,000 2.

More Definitions of Phase Ib Clinical Trial

Phase Ib Clinical Trial means a human clinical trial of a Compound, consistent with 21 C.F.R. 312.21(a) or other applicable regulatory requirements outside the United States, which is designed to determine the Maximum Tolerated Dose (with the Maximum Tolerated Dose being the highest dose of treatment that will produce the desired effect without unacceptable toxicity, intended for use in a subsequent trial).

Phase Ib Clinical Trial means any human clinical trial, typically conducted in healthy volunteers, the primary purpose of which is to characterize pharmacokinetics, pharmacodynamics and mechanism of action of an investigational drug in humans.

Phase Ib Clinical Trial means a clinical study of an investigational product in patients and/or healthy volunteers with the primary objective of characterizing its safety, tolerability and pharmacokinetics and identifying a recommended dose and regimen for future studies, as further described in 21 CFR 312.21(a) (or its successor regulation), or a comparable clinical trial prescribed by the relevant Regulatory Authority in a country other than the United States. For clarity, an expansion cohort of a Phase I Clinical Trial shall be deemed a Phase Ib Clinical Trial. The investigational product can be administered to patients as a single agent or in combination with other investigational or marketed agents.

Phase Ib Clinical Trial means a Phase I Clinical Trial in patients.

Phase Ib Clinical Trial means a human clinical trial of a Licensed Product, the principal purpose of which is a “proof on concept” in patients infected with hepatitis B conducted in accordance with 21 C.F.R. § 312.21(a) or other corresponding and similar regulatory requirements prescribed by Regulatory Authorities outside of the US.

Phase Ib Clinical Trial means an initial repeated dose, dose escalation Phase I Clinical Trial conducted in a small number of patients infected with the hepatitis C virus (HCV) to establish the safety profile of the Compound and to collect additional data on its pharmacokinetics and pharmacological effects, including antiviral activity. [***] Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

Phase Ib Clinical Trial means an oncology clinical trial of a Product (whether or not denominated a “Phase IIa” clinical trial under applicable regulations) with the principal purpose of determining if the Product works in one type of cancer and usually involves dose escalation to test safety of the Product at various dose levels. Upon mutual consensus, the Parties may negotiate to revise the definition of the Phase Ib (Phase IIa) Clinical Trial during the Term of the Agreement.