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.
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
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.

Examples of Phase 1a Clinical Trial in a sentence

  • 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.

  • The PFPG formula is as follows:PFPG = (PF1 + PF2 + PF3 + ….PFn) / nwhere:PF# = For each sample, the lowest pay factor determined from any test in Table 401‑7.

  • 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.

  • 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.

  • Allerton Avenue, South San Francisco, CA 94080 / +1 650 741-0900/myokardia.com MYK-491 for Dilated Cardiomyopathy (DCM)• Presented results from Phase 1a Clinical Trial of MYK-491 at the European Society of Cardiology Heart Failure Congress: First-in-human data from the Phase 1a clinical trial of MYK-491 in healthy volunteers showed the drug to be well tolerated.

  • 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.


More Definitions of Phase 1a Clinical Trial

Phase 1a Clinical Trial means a human Clinical Trial of a product that would satisfy the requirements of U.S. 21 C.F.R. Part 312.21(a), as amended, the principal purpose of which is a preliminary determination of safety, pharmacokinetics and pharmacodynamic parameters in healthy individuals or patients, or a similar Clinical Trial prescribed by the Regulatory Authorities in a country other than the United States.
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.

Related to Phase 1a Clinical Trial

  • Phase 1 Clinical Trial means a human clinical trial of a product in any country, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, that would satisfy the requirements of 21 C.F.R. 312.21(a), or a similar clinical study prescribed by the relevant Regulatory Authorities in a country 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 3 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(c) and is intended to (a) establish that the product is safe and efficacious for its intended use, (b) define 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.

  • Phase 4 Clinical Trial means a product support clinical trial of a Product that is commenced after receipt of MAA Approval in the country where such trial is conducted. Phase 4 Clinical Trial may include epidemiological studies, modeling and pharmacoeconomic studies and post-marketing surveillance trials.

  • 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 relatively longer and larger Phase II Clinical Study designed to study the effectiveness of different doses of a particular Product against placebo or other positive controls for a particular Indication in patients with the disease or condition under study, which is determined by the PDC to be a Phase IIB Clinical Study.

  • Phase II Clinical Trials means those trials on sufficient numbers of patients that are designed to establish the safety and biological activity of a drug for its intended use, and to define warnings, precautions and adverse reactions that are associated with the drug in the dosage range to be prescribed, as further defined in Federal Regulation 21 C.F.R. 312.21.

  • Phase III Clinical Trials means those trials on sufficient numbers of patients that are designed to establish that a drug is safe and efficacious for its intended use, and to define warnings, precautions and adverse reactions that are associated with the drug in the dosage range to be prescribed, and supporting Regulatory Approval of such drug or label expansion of such drug, as further defined in Federal Regulation 21 C.F.R. 312.21.

  • 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 II Clinical Trial means a human clinical trial in any country that is intended to initially evaluate the effectiveness of a Product for a particular indication or indications in patients with the disease or indication under study or would otherwise satisfy requirements of 21 CFR 312.21(b), or its foreign equivalent.

  • Phase III Clinical Trial means a human clinical trial in any country, the results of which could be used to establish safety and efficacy of a Product as a basis for an NDA or would otherwise satisfy requirements of 21 CFR 312.21(c), or its foreign equivalent.

  • 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 study of a Licensed Product in human patients with a defined dose or a set of defined doses of a Licensed Product designed to (a) ascertain efficacy and safety of such Licensed Product for its intended use; (b) define warnings, precautions and adverse reactions that are associated with the Licensed Product in the dosage range to be prescribed; and (c) support preparing and submitting applications for Regulatory Marketing Approval to the competent Regulatory Authorities in a country of the world, as and to the extent defined for the United States in 21 C.F.R.§ 312.21(c), or its successor regulation, or the equivalent regulation in any other country. Phase III Clinical Study shall also include any other human clinical trial serving as a pivotal study from which the data are actually submitted to the applicable Regulatory Authority in connection with a Regulatory Marketing Approval Application, whether or not such trial is called a “Phase III” study.

  • Phase II Clinical Study means, as to a particular Licensed Product for a particular indication, a controlled and lawful study in humans of the safety, dose ranging and efficacy of such Licensed Product for such indication, which is prospectively designed to generate sufficient data (if successful) to commence a Phase III Clinical Trial of such Licensed Product for such indication.

  • 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 (i) a human clinical trial of a Product that is intended to be a pivotal trial for obtaining Regulatory Approval (e.g., in the United States such clinical trial is conducted after the end of phase 2 meeting with the FDA) and to otherwise establish safety and efficacy in patients with the disease or condition being studied and to provide an adequate basis for physician labeling, for purposes of filing a MAA for Product, and that would satisfy the requirements under 21 C.F.R. 312.21(c) or foreign equivalents thereof, or (ii) any other clinical trial that is intended 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 clinical trial is a registration trial intended to be sufficient for filing an application for a Regulatory Approval for such product in the United States or another country or some or all of an extra-national territory, solely as evidenced by the acceptance for filing for a Regulatory Approval for such product after completion of such clinical trial.

  • Clinical Study or “Clinical Studies” means a Phase 1 Trial, Phase 2 Trial, Phase 3 Trial or Phase 4 Trial, or such other study in humans that is conducted in accordance with good clinical practices and is designed to generate data in support or maintenance of an NDA, MAA or other similar marketing application.

  • Clinical Studies means Phase 0, Phase I, Phase II, Phase III, 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.

  • 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 Study means a human clinical trial in any country that would satisfy the requirements of 21 C.F.R. § 312.21(a) (FDCA), as amended from time to time, and the foreign 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 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 by a Regulatory Authority 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 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 a human clinical trial of a Product in any country that satisfies the requirements of 21 C.F.R. § 312.21(a), or its foreign equivalent.