Phase 1a Clinical Trial definition

Phase 1a Clinical 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 1a Clinical Trial means a single ascending dose (“SAD”) Phase 1 Clinical Trial of a pharmaceutical product, the principal purpose of which is a preliminary determination of safety and pharmacokinetic parameters in healthy individuals.
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Phase 1a Clinical Trial means a single dose or multiple dose ascending clinical trial intended to evaluate safety and tolerability and determination of dose(s) for further clinical evaluation; and
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Examples of Phase 1a Clinical Trial in a sentence

  • As Development Lead, Molecular Partners shall be responsible for oversight of all Development activities for the Licensed Bispecific, including responsibility for all preclinical Development, conducting IND-enabling activities, and conducting the Phase 1a Clinical Trial for the Licensed Bispecific, as more particularly set forth in the Development Plan.

  • The first administration of a subject in a Phase 1a Clinical Trial of any Licensed Technology, Licensed Compound or Licensed Product.

  • Molecular Partners, either itself or through a Third Party contract manufacturing organization (a “CMO”) reasonably acceptable to Amgen, shall supply pre-clinical and clinical quantities (for the Phase 1a Clinical Trial) of the Licensed Bispecific for the Development of the Licensed Bispecific in accordance with this Agreement, including out of any inventory of the Licensed Bispecific existing as of the Effective Date.

  • Upon completion of the Phase 1a Clinical Trial for the Licensed Bispecific, the Parties shall initiate a process to transfer the Development Lead role to Amgen as expeditiously as practicable.

  • Our Phase 1a Clinical Trial and Ongoing Phase 1b/2 Clinical Trial In 2017, we completed a Phase 1a clinical trial in Australia to assess the safety, tolerability, PK, PD and immunomodulatory activity of KZR-616 in 82 healthy volunteers.

  • Upon completion of the Phase 1a Clinical Trial for the Licensed Bispecific (i.e., after the last patient has been dosed and generation of the report form for the Phase 1a Clinical Trial), the Parties shall initiate a process to transfer the Regulatory Lead role to Amgen as expeditiously as practicable.

  • Reasonably prior to Molecular Partners’ Initiation of the Phase 1a Clinical Trial of the Combination Therapy, the Parties shall define and allocate each Party’s responsibilities with respect to pharmacovigilance activities for the Licensed Bispecific, Combination Therapies and MP Combination Therapies under a written agreement (the “Safety Agreement”).

  • Molecular Partners shall be solely responsible for all Development Costs incurred by or on behalf of Molecular Partners or its Affiliates with respect to Development activities related to the Phase 1a Clinical Trial for the Licensed Bispecific.


More Definitions of Phase 1a Clinical Trial

Phase 1a Clinical Trial means a Clinical Trial of a product in combination or as a monotherapy, the principal purpose of which is a preliminary determination of safety, pharmacokinetic, and pharmacodynamic parameters in healthy individuals or patients, as described in 21 C.F.R. 312.21(a) (as amended or any replacement thereof), or a similar clinical trial prescribed by the Regulatory Authority in a country other than the United States.
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Phase 1a Clinical Trial means a Clinical Trial of a product, the principal purpose of which is a preliminary determination of [***], and that satisfies the requirements of 21 C.F.R. § 312.21(a) or its non-U.S. equivalents.
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Phase 1a Clinical Trial means the Phase 1 Clinical Trial monotherapy dose escalation activities for the Licensed Bispecific, the principal purpose of which is a preliminary determination of safety, tolerability, or pharmacokinetics, as further defined in the Development Plan.
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Phase 1a Clinical Trial means a human clinical trial of a product, the principal purpose of which is a preliminary determination of safety, pharmacokinetic, and pharmacodynamic parameters in healthy individuals or patients, or a similar clinical study prescribed by the Regulatory Authorities. “Phase 1B Clinical Trial” shall mean a human clinical trial of a product: (a) the principal purpose of which is to evaluate safety and tolerability of the drug following repeat dosing in patients and (b) the secondary purpose of which is to evaluate biomarker-based and clinical endpoint-based trends of efficacy, conducted after the initiation of an initial Phase 1 Clinical Trial or Phase 1A Clinical Trial of such product, prior to commencement of Phase 2 Clinical Trials or Phase 3 Clinical Trials, and that is designed to provide (itself or together with other available data) evidence of sufficient safety and clinical activity to enable the decision to proceed to a Phase 2 Clinical Trial, or any comparable trial as defined or referenced under applicable Laws. “Phase 2 Clinical Trial” means a human clinical trial of a product designed to satisfy the requirements of 21 C.F.R. § 312.21(b) and intended to explore a variety of doses, dose response, and duration of effect, and to generate data on side effects and clinical efficacy for a particular indication or indications in a target patient population, or any comparable trial under applicable Laws. “Phase 3 Clinical Trial” means a human clinical trial of a product designed to satisfy the requirements of 21 C.F.R. § 312.21(c) and is intended to (a) establish that the product is safe and efficacious for its intended use, (b) define contraindications, warnings, precautions and adverse reactions that are associated with the product in the dosage range to be prescribed, and (c) support Regulatory Approval for such product, or any comparable trial under applicable Laws. “Phase 4 Clinical Trial” means a human clinical trial, or other test or study, of a product for an indication that is commenced after receipt of the initial Regulatory Approval for such indication and that is conducted within the parameters of the Regulatory Approval for the product for such indication (and which may include investigator sponsored clinical trials), including a clinical trial conducted due to the request or requirement of a Regulatory Authority or as a condition of a previously granted Regulatory Approval. “Pre-Clinical Development” means activities reasonably relating t...
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Related to Phase 1a Clinical Trial

  • 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 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 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 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.

  • 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 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.

  • 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 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 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 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 the JDC and that otherwise fit the foregoing definition.

  • 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 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).

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

  • 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.

  • Pivotal Clinical Trial means a human clinical trial in any country that is prospectively designed to generate data intended to satisfy the requirements of 21 C.F.R. § 312.21(c) (as amended) in the U.S. or a similar clinical study prescribed by a Regulatory Authority from another country, from time to time, pursuant to Applicable Law.

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

  • Clinical Studies means human clinical trials for a Licensed Product and any other tests and studies for a Licensed Product in human subjects.

  • 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 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 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).

  • 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 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 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 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 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).