Phase 1 Clinical Trial definition

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 1 Clinical Trial means a human clinical trial of a Licensed Product that would satisfy the requirements of 21 C.F.R. 312.21(a) or corresponding foreign regulations.

Phase 1 Clinical Trial means a human clinical trial of a Product, the principal purpose of which is to determine initial tolerance or safety of such Product in the target patient population, or in the United States, is otherwise consistent with a human clinical trial as described in 21 CFR 312.21(a), or, in a country other than the United States, a similar clinical study prescribed by the applicable Regulatory Authority. With respect to the milestone payments set forth in Section 4, a Phase 1 Clinical Trial shall be deemed started upon the first dosing of the first subject of the first Phase 1 Clinical Trial.

Examples of Phase 1 Clinical Trial in a sentence

• Subject to the terms of this Agreement, and no later than three (3) months prior to the initiation of the first Phase 1 Clinical Trial, Ambrx and BMS (under the guidance of their respective Pharmacovigilance Departments, or equivalent thereof) shall enter into a written agreement setting forth the responsibilities of the Parties to protect patients and promote their well-being in connection with the use of the Compounds and Products (the “Safety Data Exchange Agreement” or “SDEA”).

• Upon request by BMS, Ambrx will use Diligent Efforts to obtain from its Third Party manufacturers the supply of Raw Materials reasonably requested by BMS for use by BMS in the manufacture of Compound prior to the initiation of a Phase 1 Clinical Trial for Product, provided that BMS shall be responsible for reimbursing Ambrx for its Third Party Costs incurred in connection with such supply of such Raw Materials.

• The Report concluded:The carer research literature contains multiple recommendations for well-designed randomised controlled trials and, in our view there is no doubt that these are required to strengthen the evidence base for carer interventions.

• If a Phase 1 Clinical Trial is conducted for a Development Candidate in a given Program, within [***] ([***]) days after Data Lock for the applicable Clinical Trial ([***]), Prothena shall provide to Celgene (or a Third Party advisor designated by Celgene) the Phase 1 Data Package for such Program.

• During the Research Term, for each Collaboration Target, Prothena may conduct discovery activities to characterize, identify and generate Antibodies to become Collaboration Candidates that Target such Collaboration Target, and thereafter may pre-clinically Develop Collaboration Candidates to identify Lead Candidates that Target such Collaboration Target and File an IND with the FDA for a Phase 1 Clinical Trial for such Lead Candidates.

More Definitions of Phase 1 Clinical Trial

Phase 1 Clinical Trial means the initial clinical testing of a Product in humans (first-in-humans study) with the intention of gaining a preliminary assessment of the safety of such Product.

Phase 1 Clinical Trial means a clinical trial as defined in 21 C.F.R. 312.21(a), as may be amended from time to time, or any foreign equivalent thereto.

Phase 1 Clinical Trial means a clinical trial in humans which provides for the first introduction into humans of a pharmaceutical product, to generate information on product safety, tolerability, pharmacological activity or pharmacokinetics, as described in Federal Regulation 21 C.F.R. §312.21(a) and its foreign equivalents.

Phase 1 Clinical Trial means a Clinical Study 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 CFR 312.21(a), or an equivalent clinical study required by a Regulatory Authority in a jurisdiction outside of the United States.

Phase 1 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), or a similar clinical study prescribed by the Regulatory Authorities in a foreign country, and is intended to (a) determine the safety, pharmacokinetics and pharmacodynamic parameters in healthy individuals or patients, and (b) following the foregoing clause (a), further evaluate safety and pharmacokinetics (including exploration of trends of a biomarker-based or clinical endpoint-based efficacy relationship to dose which need not be designed to be statistically significant) of the product, whether or not in combination with concomitant treatment and which provides sufficient evidence of safety to be included in filings for a Phase 2 Clinical Trial or a Registration Enabling Clinical Trial with Regulatory Authorities.

Phase 1 Clinical Trial means a controlled human clinical trial that would satisfy the requirements of 21 C.F.R. 312.21(a) or foreign equivalents thereof; “Phase 2 Clinical Trial” means a controlled human clinical trial that would satisfy the requirements of 21 C.F.R. 312.21(b) or foreign equivalents thereof; “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.

Phase 1 Clinical Trial means a human clinical trial of a compound, 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), or a similar clinical study prescribed by the Regulatory Authorities in a foreign country.