Phase 1b Clinical Trial definition

Phase 1b Clinical Trial means a study in humans which provides for the first introduction of a pharmaceutical product into patients having the disease of interest with the primary purpose of determining safety, metabolism and pharmacokinetic properties and clinical pharmacology of such product, in a manner which is consistent with U.S. 21 C.F.R. § 312.21(a) or its foreign equivalents.

Phase 1b Clinical Trial means a Phase 1 Clinical Trial in the target patient population that is designed to establish safety and immunogenicity, which may also be designed to establish an initial indication of efficacy.

Phase 1b Clinical Trial means a human clinical trial of a compound, the principal purpose of which is a further determination of safety and pharmacokinetics (including exploration of trends of a biomarker-based or clinical endpoint-based efficacy relationship to dose which are not designed to be statistically significant) of the compound whether or not in combination with concomitant treatment after an initial Phase 1a Clinical Trial, prior to commencement of Phase 2 Clinical Trials or Phase 3 Clinical Trials, and which provides (itself or together with other available data) sufficient evidence of safety to be included in filings for a Phase 2 Clinical Trial or a Phase 3 Clinical Trial with Regulatory Authorities, or a similar clinical study prescribed by the Regulatory Authorities in a foreign country.

Examples of Phase 1b 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 [***].

• Agenus shall provide Gilead with the Data Package with respect to the first completed Phase 1b Clinical Trial of an Initial Licensed Product which meets the Clinical Trial Criteria promptly following the completion of such Phase 1b Clinical Trial.

• In addition, the Parties will agree upon an amendment to the Agenus Development Plan in order to ensure that such plan is designed to enable Agenus to, during the Option Period, provide Gilead with the Data Package with respect to the first completed Phase 1b Clinical Trial of an Initial Licensed Product which meets the Clinical Trial Criteria.

• Notwithstanding Section 2.3.1, [******] during the period from the Effective Date until the first completed Phase 1b Clinical Trial of an Initial Licensed Product which meets the Clinical Trial Criteria, Gilead may provide written notice to Agenus requesting a Data Package (each, a “Data Package Request Notice”).

• A Successful Completion of a Phase 1b Clinical Trial will be defined the same as a Successful Completion of a Phase 2 Clinical Trial with at least a twenty percent (20%) objective response rate.

More Definitions of Phase 1b Clinical Trial

Phase 1b Clinical Trial means [******].

Phase 1b Clinical Trial means a multiple ascending dose (“MAD”) Phase 1 Clinical Trial of a pharmaceutical product, the principal purpose of which is a further determination of safety, pharmacokinetic, and pharmacodynamic (i.e., measurement of plasma HCV RNA) parameters of the pharmaceutical product in patients.

Phase 1b Clinical Trial means a pilot human clinical trial usually conducted in patients diagnosed with the disease, or condition for which the study drug is intended, who demonstrate some biomarker, surrogate, or possible clinical outcome.

Phase 1b Clinical Trial means a clinical trial, or arm thereof, of an investigational product in patients (a) with the primary objective of characterizing its safety, tolerability, and pharmacokinetics and identifying a recommended dose and regimen for future studies as described in 21 C.F.R. 312.21(a), as amended from time to time, or a comparable clinical trial prescribed by the relevant Regulatory Authority in a country other than the United States and (b) with the additional purpose of identifying a recommended dose for a Phase 2 Clinical Trial or Pivotal Clinical Trial based on the review of the maximum tolerated dose during the dose escalation phase together with additional data and safety considerations obtained during the expansion phase.

Phase 1b Clinical Trial means, as to a specific Licensed Product, a human clinical trial in patients in any country that is intended as a study of such product designed to satisfy the requirements of 21 C.F.R. § 312.21(a) in the United States, as amended from time to time, or the corresponding regulation in jurisdictions other than the United States.

Phase 1b Clinical Trial means the first safety trial in patients with pulmonary arterial hypertension (PAH) of the initial License Product that would also satisfy the requirements of 21 CFR § 312.21(a).

Phase 1b Clinical Trial means that portion of a Phase 1 Clinical Trial for a Collaboration Compound or Collaboration Product after the phase 1a portion of such trial that provides for the initial evaluation of a Collaboration Compound or Collaboration Product on a larger number of patients in a controlled clinical study, designed to evaluate further the safety and to provide initial indications of the effectiveness of a product for a particular indication in patients with the disease or condition under safety and to seek to determine a dose that is effective and sufficiently tolerated with respect to the proposed therapeutic indication.