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 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).
Examples of Phase Ib Clinical Trial in a sentence
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Safety and Efficacy of PD-1 Antibody SHR-1210 Combined with Concurrent Chemoradiotherapy to Treat Locally Advanced Esophageal Squamous Cell Carcinoma: A Phase Ib Clinical Trial Q.
More Definitions of Phase Ib Clinical Trial
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.
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). 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 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 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 a Clinical Trial: (a) the principal purpose of which is to evaluate safety and tolerability following repeat dosing in patients and (b) the secondary purpose of which may be to evaluate biomarker-based or clinical endpoint-based trends of efficacy, conducted after the initiation of an initial Phase I Clinical Trial or Phase Ia Clinical Trial. A Phase Ib Clinical Trial may be prospectively designed to generate sufficient data (if successful) to commence a Phase II Clinical Trial or a Phase III Clinical Trial or, in some instances, to submit an application for Regulatory Approval, which may include accelerated approval under section 506(c) of the FDCA or conditional approval under analogous Applicable Law in other countries.