Phase Ib Clinical Trial definition

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 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 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

• 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.

• 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 [***].

• 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.

• Figure 1 Phase Ib Clinical Trial ProcessSentinels: when each group enrolls subjects, the first 6 subjects will be "sentinels".

• DOV shall conduct at its expense a Phase Ib Clinical Trial with respect to DOV 21,947 (the “Phase Ib”) on normal volunteers in order to form a basis for a Phase II Clinical Trial with respect to DOV 21,947, as more fully described below (the “First Phase II”).

More Definitions of Phase Ib Clinical Trial

Phase Ib Clinical Trial means a human clinical trial of a Licensed Product, 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 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 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 Phase I clinical trial of any pharmaceutical product, the principal purpose of which is to determine the optimal safe dose through dose escalation.

Phase Ib Clinical Trial means a Clinical Trial of a compound, the principal purpose of which is a further determination of safety and pharmacology of the compound after an initial Phase Ia Trial, and prior to Commencement of Phase II Clinical Trials or Phase III Clinical Trials, and which provides (itself or together with other available Data) sufficient evidence of safety to be included in filings for a Phase II Clinical Trial or a Phase III Clinical Trial with Regulatory Authorities, or a similar Clinical Trial prescribed by the Regulatory Authorities in a foreign country. [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. Confidential Treatment Requested by Codexis, Inc.