Phase Ia Trial definition

Phase Ia Trial means a human clinical trial of a compound, the principal purpose of which is a preliminary determination of safety, pharmacokinetics, and pharmacodynamic parameters in healthy individuals or patients, as described in 21 C.F.R. 312.21(a), or a similar clinical study prescribed by the Regulatory Authorities in a foreign country.
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Phase Ia Trial means the clinical trial activities contemplated under the Pre-Option Development Plan or an initial clinical trial of a Product under this Agreement that: (a) is a first-in-humans trial on subjects who are healthy volunteers or patients; (b) is for the purposes of establishing initial safety, tolerability, pharmacokinetic and pharmacodynamic Information for the Product; (c) exposes subjects to a single dose of the Product; and (d) is designed to provide the sponsor of the clinical trial with sufficient Information about the Product to initiate a Phase Ib Trial.
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Phase Ia Trial means the second phase in the Committee Litigation at which various parties will litigate, if necessary, the solvency of each individual Debtor, and any related or appropriate remedy as a result, all as described in the Committee Litigation Management Order.
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Examples of Phase Ia Trial in a sentence

  • Licensee shall have the right (through the JDT after the JDT is formed), to review and provide comments on Development activities with respect to the Relay Phase Ia Trial and to withhold approval of any Development activities that may, in Licensee’s good faith belief, conflict with, or have a negative impact on, Licensee’s Development activities with respect to Licensed Candidates or Licensed Products (including Licensee’s activities under the Global Development Plan during an Opt-In Term).

  • Relay will also provide notice to Licensee and the opportunity to review and approve any decision for which Licensee has final decision making rights with respect to the Relay Phase Ia Trial under Section 10.7.3(b).

  • Payment of remuneration on termination (2) Pension benefits due to an employee shall be paid within six weeks of the termination or completion of the contract of employment.

  • While WDT strives for accuracy, the cost sheet may not reflect the exact costs for any program.

  • With respect to a Requested Additional Phase Ia Study the Parties will, through the JDT, discuss in good faith whether the Requested Additional Phase Ia Study can and should be conducted as part of and with the same patient population as the existing or planned Relay Phase Ia Trial, or whether it should be conducted as a separate study by Licensee, taking into consideration strategic factors and timing and resource considerations.

  • Fasso, A.D. Colevas Long-Term Safety and Clinical Outcomes of pembrolizumab in Head and Neck Cancer: Phase Ia Trial Results Annals of Oncology (2017) 28 (suppl_5): v372-v394.

  • Relay will continue to conduct the Relay Phase Ia Trial in accordance with accepted pharmaceutical industry norms and ethical practices and in accordance with the Relay Phase Ia Plan as disclosed to Licensee prior to the Execution Date.

  • Concurrently with or after delivery of such report, Relay will deliver an invoice to Licensee for Licensee’s share of such Relay Phase Ia Trial CRO Costs.

  • Financial risk management objectives and policies The Board of Directors monitors and manages the financial risks relating to the operations of the Company through internal risk reports which analyse exposures by degree and magnitude of risks.

  • Licensee will provide Relay with written notice of completion of the Immediate Tech Transfer Activities or achievement of the IND Transfer Milestone or the Relay Phase Ia Trial Milestone, as applicable, promptly after Licensee’s confirmation of the achievement thereof and confirmation that Relay is in material compliance with all of its obligations with respect to the Technology Transfer and relevant obligations under Sections 3.2, 3.3, 3.4, 3.9.1, 6.3 and 6.4 through such date.


More Definitions of Phase Ia Trial

Phase Ia Trial means a Phase I Trial the principal purpose of which is: (a) preliminary determination of initial safety, tolerability, and pharmacokinetics in subjects; (b) exposes subjects to one or more dose(s) of the Licensed Product and (c) is designed to provide the sponsor of the clinical trial with sufficient information about the Product to initiate a subsequent trial, e.g., a dose expansion phase of the Phase I Trial (e.g., Phase Ib Trial). For clarity, [*].
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Related to Phase Ia Trial

  • Phase I Trial means a Clinical Trial, the principal purpose of which is preliminary determination of safety of an investigational product in healthy individuals or patients or that otherwise meets the requirements described in 21 C.F.R. §312.21(a), or similar Clinical Trial in a country other than the United States.

  • Phase II Trial means a clinical trial of a Licensed Product on patients, including possibly pharmacokinetic and dose ranging studies, the principal purposes of which are to make a preliminary determination that such Licensed Product is safe for its intended use and to obtain sufficient information about such Licensed Product’s efficacy to permit the design of further clinical trials, and generally consistent with 21 CFR §312.21(b), or its successor regulation, or the equivalent in any foreign country.

  • Phase 3 Trial means a human clinical trial of a Product on a sufficient number of subjects that is designed to establish that a pharmaceutical product is safe and efficacious for its intended use, and to determine warnings, precautions and adverse reactions that are associated with such pharmaceutical product in the dosage range to be prescribed, which trial is intended to support Approval of a Product, as described in 21 C.F.R. 312.21(c) for the United States, or a similar clinical study prescribed by the Regulatory Authorities in a foreign country.

  • Phase 2 Trial means a human clinical trial conducted on study subjects with the disease or condition being studied for the principal purpose of achieving a preliminary determination of efficacy or appropriate dosage ranges, as further described in 21 C.F.R. §312.21(b) (including any such clinical study in any country other than the United States).

  • Phase III Trial means a Clinical Trial of an investigational product in subjects that incorporates accepted endpoints for confirmation of statistical significance of efficacy and safety with the aim to generate data and results that can be submitted to obtain Regulatory Approval as described in 21 C.F.R. 312.21(c), or a comparable Clinical Trial prescribed by the relevant Regulatory Authority in a country other than the United States.

  • Phase I Study means a study in humans which provides for the first introduction into humans of a product, conducted in healthy volunteers or patients to obtain information on product safety, tolerability, pharmacological activity or pharmacokinetics, as more fully defined in 21 C.F.R. § 312.21(a) (or the non-United States equivalent thereof).

  • Phase 1 Trial means, with respect to a Licensed Product, a clinical trial (or — in case of a multi-phase clinical trial — those parts of a clinical trial) in line with the provisions of 21CFR312, Section 21 (a).

  • Phase II Study means a human clinical trial, for which the primary endpoints include a determination of dose ranges and/or a preliminary determination of efficacy in patients being studied as described in 21 C.F.R. § 312.21(b) (FDCA), as amended from time to time, and the foreign equivalent thereof.

  • Phase III Study means a human clinical trial that is prospectively designed to demonstrate statistically whether a product is safe and effective for use in humans in a manner sufficient to obtain regulatory approval to market such product in patients having the disease or condition being studied as described in 21 C.F.R. § 312.21(c) (FDCA), as amended from time to time, and the foreign equivalent thereof.

  • Phase IIb Clinical Trial means a clinical trial of a Product on sufficient numbers of patients that is designed to provide a preliminary determination of safety and efficacy of such Product in the target patient population over a range of doses and dose regimens.

  • Phase 1 Study means a clinical study of a drug candidate in human patients 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), or a comparable clinical study prescribed by the relevant Regulatory Authority in a country other than the United States. The drug candidate can be administered to patients as a single agent or in combination with other investigational or marketed agents.

  • Phase 3 Study means a clinical study of a drug candidate in human patients that incorporates accepted endpoints for confirmation of statistical significance of efficacy and safety with the aim to obtain Regulatory Approval in any country as described in 21 C.F.R. 312.21(c), or a comparable clinical study prescribed by the relevant Regulatory Authority in a country other than the United States. The relevant drug candidate may be administered to patients as a single agent or in combination with other investigational or marketed agents.

  • Phase I Clinical Trial means a human clinical trial that is intended to initially evaluate the safety and/or pharmacological effect of a Product in subjects or that would otherwise satisfy requirements of 21 C.F.R. 312.21(a), or its foreign equivalent.

  • Phase III means human clinical trials, the principal purpose of which is to establish substantial evidence of both safety and efficacy in patients with the disease or condition being studied, as more fully defined in 21 C.F.R. §312.21(c) or similar clinical study in a country other than the United States. Phase III shall also include any other human clinical trial intended to serve as a pivotal trial to support the submission of an application for regulatory approval.

  • Phase II Clinical Trial means a controlled human clinical study that would satisfy the requirements of 21 CFR 312.21(b), conducted to study the effectiveness and establish the dose range of a Product for a particular Indication in patients with the disease or condition under study, including a Phase IIA Clinical Study or Phase IIB Clinical Study.

  • Phase II Clinical Study means a human clinical study of a product initiated to determine the safety and efficacy in the target patient population, as described 21 C.F.R. 312.21(b).

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • Phase 2 Clinical Trial means a human clinical trial, for which the primary endpoints include a determination of dose ranges or an indication of efficacy in patients being studied as described in 21 C.F.R. §312.21(b), or an equivalent clinical trial in a country in the Territory other than the United States.

  • Phase 1 Clinical Trial means a Clinical Trial of a Product on sufficient numbers of normal volunteers and/or patients that is designed to establish that such Product is safe for its intended use and to support its continued testing in Phase 2 Clinical Trials. For purposes of this Agreement, ‘initiation’ of a Phase 1 Clinical Trial for a Product means the first dosing of such Product in a human subject in a Phase 1 Clinical Trial.

  • Clinical Trial means any human clinical trial of a Product.

  • Phase 3 Clinical Trial means a pivotal clinical trial in humans performed to gain evidence with statistical significance of the efficacy of a product in a target population, and to obtain expanded evidence of safety for such product that is needed to evaluate the overall benefit-risk relationship of such product, to form the basis for approval of an NDA and to provide an adequate basis for physician labeling, as described in 21 C.F.R. § 312.21(c) or the corresponding regulation in jurisdictions other than the United States.

  • Phase III Clinical Study means a trial involving administration of a Compound to sufficient numbers of human patients with the goal of establishing that the Compound is safe and efficacious for its intended use, to define warnings, precautions and adverse reactions that are associated with the drug or label expansion of such Compound, and to be considered as a pivotal study for submission of an NDA.

  • Phase III Clinical Trial means a human clinical trial of a product, the design of which is acknowledged by the FDA to be sufficient for such clinical trial to satisfy the requirements of 21 C.F.R. 312.21(c) (as amended or any replacement thereof), or a similar human clinical trial prescribed by the Regulatory Authority in a country other than the United States, the design of which is acknowledged by such Regulatory Authority to be sufficient for such clinical trial to satisfy the requirements of a pivotal efficacy and safety clinical trial.

  • Phase 3 means the period commencing on the day after the Phase 2 implementation date and ending on the Phase 3 implementation date (as defined below).

  • Clinical Study means a Phase I Study, Phase II Study, Phase III Study, as applicable.

  • Phase 4 Clinical Trial means a Clinical Trial of a Product conducted after Regulatory Approval of such Product has been obtained from an appropriate Regulatory Authority, which trial is (a) conducted voluntarily by a Party to enhance marketing or scientific knowledge of the Product, or (b) conducted due to a request or requirement of a Regulatory Authority.