Phase I Clinical Studies definition

Phase I Clinical Studies means that portion of the clinical DEVELOPMENT PLAN or DEVELOPMENT WORK which provides for the first introduction into humans of a COMPOUND or PRODUCT including one or more small scale clinical studies conducted in normal volunteers or patients to get INFORMATION on PRODUCT safety, tolerability, pharmacological activity or pharmacokinetics as more fully defined in 21 C.F.R. 312.21(a).
Sample 1Sample 2Sample 3
Phase I Clinical Studies means a limited series of studies in patients or healthy volunteers whose primary purpose is to evaluate the safety and pharmacokinetics of a Product in any indication.
Sample 1Sample 2Sample 3
Phase I Clinical Studies means those studies that include the initial introduction of a drug into humans, to determine the metabolic and pharmacologic actions of the drug (as a single agent or in combination) in humans, as more fully defined in 21 C.F.R. §312.21(a), or its successor regulation, or the equivalent in any foreign country.
Sample 1Sample 2

Examples of Phase I Clinical Studies in a sentence

  • For each Development Candidate, the Parties (jointly or unilaterally) may conduct IND-enabling Non- Clinical Studies (such as pharmacokinetics studies, metabolism studies, toxicology studies and genotoxicity studies) to characterize such Development Candidate and to determine whether to further pursue Development of such Development Candidate in Phase I Clinical Studies.

  • For each Development Candidate, the JRDI shall evaluate the results generated from the IND-enabling Non-Clinical Studies conducted as described in Section 4.2(c) (whether jointly or unilaterally) pertaining to such Development Candidate to determine whether to file an IND for such Development Candidate in order to further Develop such Development Candidate in Phase I Clinical Studies.

  • The Parties (jointly or unilaterally) may Develop each Development Candidate in Phase I Clinical Studies for which an IND has been filed.

  • From time to time during the Term, the Parties may mutually agree to amend the Development Plan to include additional Development activities to be conducted by PEI, including the conduct of certain Phase I Clinical Studies, Phase II Clinical Studies or aspects or tasks associated with Phase III Clinical Studies.

  • The JRDI shall evaluate the results obtained from such Phase I Clinical Studies and determine whether to further Develop such Development Candidate in Indication Survey Studies as described in Section 4.2(e)(ii) below or other Phase II Clinical Studies to further characterize such Development Candidate prior to it being designated, if at all, as a Product Candidate.

  • If requested by Licensee, Meiji shall supply the Product for the development use during the Phase I Clinical Studies for the first Product and - but only if reasonably necessary to prevent disruption of Product development - the Phase II Clinical Studies for the first Product (for the avoidance of doubt, Phase II Clinical Studies are not Pivotal Clinical Studies).

  • The Parties intend to enter into such Manufacturing Agreements (i) no later than [***] prior to the Initiation of Phase I Clinical Studies for the first Licensed Product (for the clinical manufacturing agreement) and (ii) no later than [***] prior to the anticipated date of Regulatory Approval of the first Licensed Product (for the commercial manufacturing agreement).

  • In the case where both parties have identified the same Development Compound in accordance with Section 5.1 above, the party first commencing Phase I Clinical Studies shall be determined to have rights for further development and commercialization of such Development Compound, provided that such party properly delivered a Compound Selection Notice pursuant to Section 5.1(a).

  • The Parties intend to enter into such a Manufacturing Agreement for clinical supplies of Licensed Products no later than [**] prior to the Initiation of Phase I Clinical Studies with respect to the first Licensed Product and a Manufacturing Agreement for commercial supply of Licensed Products no later than [**] prior to the anticipated date of Regulatory Approval for the first Licensed Product.

  • The Clinical Study Reserve shall be used by LIMINATUS and TDT for the sole purpose of funding efforts in respect of the conduct of the United States Phase I Clinical Studies for the CAR T Products.


More Definitions of Phase I Clinical Studies

Phase I Clinical Studies means the portion of the clinical development program which provides for the first introduction into humans of a Product including small scale clinical studies conducted in normal volunteers or patients to get information of the Product's safety, tolerability, pharmacological activity or pharmacokinetics, as more fully defined in 21 C.F.R. 312.21(a).
Sample 1Sample 2
Phase I Clinical Studies means the type of studies defined in 21 C.F.R. 312.21(a) or any successor to such provision and the foreign equivalent thereof.
Sample 1Sample 2
Phase I Clinical Studies will mean those studies that include the initial introduction of a drug into humans to determine the metabolic and pharmacologic actions of a drug in humans, the side effects associated with increasing doses and if possible to gain early evidence on effectiveness. Phase I Clinical Studies may also evaluate drug metabolism, structure-activity relationships, and the mechanism of action in humans. Phase I Clinical Studies will not include Phase I clinical studies designed to evaluate parameters regarding a transdermal drug delivery system other than pharmacokinetic and pharmacodynamic parameters of the Compound, such as suitability of adhesives, skin tolerability or irritation.
Sample 1

Related to Phase I Clinical Studies

  • Phase I Clinical Study means, as to a particular Licensed Product, an initial clinical study in humans with the purpose of assessing the Licensed Product’s safety, tolerability, toxicity, pharmacokinetics or other pharmacological properties.

  • Phase I Clinical Trial means a study in humans which provides for the first introduction into humans of a product, conducted in normal volunteers or patients to generate information on product safety, tolerability, pharmacological activity or pharmacokinetics, or otherwise consistent with the requirements of U.S. 21 C.F.R. §312.21(a) or its foreign equivalents.

  • 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 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 4 Clinical Trial means a Clinical Study in any country which is conducted after Regulatory Approval of a product has been obtained from an appropriate Regulatory Authority, consisting of trials conducted voluntarily for enhancing marketing or scientific knowledge of an approved indication and trials conducted due to request or requirement of a Regulatory Authority.

  • 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 III Clinical Trials means a Clinical Trial for the Product on sufficient numbers of patients to generate safety and efficacy data to support Regulatory Approval in the proposed therapeutic indication, conducted in accordance with current good clinical practices and in accordance with a protocol that has been reviewed by the FDA and reflects any comments or concerns raised by the same.

  • Clinical Studies means Xxxxx 0, Xxxxx 0, Xxxxx 0, Xxxxx 3, and such other tests and studies in human subjects that are required by Applicable Law, or otherwise recommended by the Regulatory Authorities, to obtain or maintain Regulatory Approvals for a Licensed Product for one (1) or more indications, including tests or studies that are intended to expand the Product Labeling for such Licensed Product with respect to such indication.

  • 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 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 2 Clinical Trial means a human clinical trial of a product in any country that would satisfy the requirements of 21 C.F.R. 312.21(b) and is intended to explore a variety of doses, dose response, and duration of effect, and to generate initial evidence of clinical safety and activity in a target patient population, or a similar clinical study prescribed by the relevant Regulatory Authorities in a country 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.

  • Phase III Clinical Trial means a large, controlled or uncontrolled Clinical Study that would satisfy the requirements of 21 CFR 312.21(c), intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis for physician labeling.

  • Phase IV Clinical Trial means a product support clinical trial of a Product commenced after receipt of Regulatory Approval in the country where such trial is conducted. A Phase IV Clinical Trial may include epidemiological studies, modeling and pharmacoeconomic studies, and investigator-sponsored clinical trials studying Product that are approved by BMS and that otherwise fit the foregoing definition.

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

  • 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).

  • Clinical Trials means a controlled study in humans of the safety or efficacy of a Product, and includes, without limitation, such clinical trials as are designed to support expanded labeling or to satisfy the requirements of an Agency in connection with any Product Approval and any other human study used in research and Development of a Product.

  • Clinical Trial means a Phase I Clinical Trial, Phase II Clinical Trial or Phase III Clinical Trial, or any post-approval human clinical trial, as applicable.

  • Pivotal Clinical Trial means a pivotal human clinical trial of a Licensed Product with a defined dose or a set of defined doses of such Licensed Product designed to ascertain efficacy and safety of such Licensed Product for the purpose of enabling the preparation and submission of an MAA to the competent Regulatory Authorities in a country of the Territory, as further defined in 21 C.F.R. § 312.21(c) for the U.S., as amended from time to time, or the corresponding foreign regulations.

  • Approved clinical trial means a phase I, phase II, phase III, or phase IV clinical trial that is conducted in relation to the prevention, detection, or treatment of cancer or other life-threatening disease or Condition and is described in any of the following:

  • Phase I Trial means a clinical trial of a Licensed Product in human patients conducted primarily for the purpose of determining the safety, tolerability and preliminary activity of the Licensed Product, including, without limitation, for determining the maximum tolerated dose, or optimal dose. For purposes of this Agreement, a Phase I trial shall specifically exclude a study in healthy volunteers.

  • 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 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.

  • Clinical means having a significant relationship, whether real or potential, direct or indirect, to the actual rendering or outcome of dental care, the practice of dentistry, or the quality of dental care being rendered to a patient;

  • Subject of a Clinical Trial means the health care service, item, or drug that is being evaluated in the Approved Clinical Trial and that is not a Routine Patient Cost.

  • Phase 3 Study means a clinical study of an investigational product in 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 investigational product can be administered to patients as a single agent or in combination with other investigational or marketed agents [***]