Phase 1 Clinical Trial definition

Phase 1 Clinical Trial means, as to a specific Licensed Product or Licensed Service, a study as described in 21 C.F.R. §312.21(a) or a comparable clinical study 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 1 Clinical Trial means a human clinical trial 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), or a similar clinical study prescribed by the relevant Regulatory Authorities in a country other than the United States.

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.

• As soon as possible, but in all cases within [***] ([***]) months after Data Lock for the applicable Clinical Trial, Prothena shall provide to Celgene (or a Third Party advisor designated by Celgene) the final study report for the Phase 1 Clinical Trial for such Program (which shall be prepared in accordance with customary practice that meets the standards of ICH Topic E3 of ICH Guidelines for Structure and Content of Clinical Study Reports dated July 1996).

• 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.

• Just as the right to express and disseminate ideas is indivisible as a concept, so too must it be recognized that the only restrictions that may be placed on the mass media are those that apply to freedom of expression.

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 in any country conducted in a small number of human volunteers designed or intended to establish an initial safety profile, pharmacodynamics, or pharmacokinetics of a Product. For clarity, a Phase 1 Clinical Trial may include studies conducted in oncology patients.

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, as to a particular Licensed Product, a lawful study in humans of the safety and dose ranging of such Licensed Product, which is prospectively designed to generate sufficient data (if successful) to commence a Phase 2 Clinical Trial of such Licensed Product.

Phase 1 Clinical Trial means a study of a pharmaceutical product in humans to determine safety and toxicity before embarking on Phase 2 Clinical Trials, as further defined in 21 C.F.R. 312.21(a), as amended from time to time, or the corresponding foreign regulations.

Phase 1 Clinical Trial means the first lawful study in humans, conducted in accordance with 21 C.F.R. §312.21(a) (or the equivalent LAWS and regulations in jurisdictions outside the United States). [***] indicates that certain information contained herein has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.