Phase 1 Clinical Trial definition

Phase 1 Clinical Trial means, as to a specific pharmaceutical product, a Clinical Trial in humans of the safety of such product in healthy volunteers or a limited patient population, or human clinical studies directed toward understanding the mechanisms or metabolism of the product. A Phase 1 Clinical Trial shall be deemed initiated upon the dosing of the first subject or patient.

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Phase 1 Clinical Trial means any Clinical Trial as described in 21 C.F.R. §312.21(a), or, with respect to a jurisdiction other than the United States, a similar Clinical Trial.

Phase 1 Clinical Trial means, as to a specific Licensed Product, a human clinical trial of a product in any country designed to satisfy the requirements of 21 C.F.R. §312.21(a) as amended from time to time, and intended to determine metabolism and pharmacologic actions of a drug in humans, the side effects associated with increasing doses and, if possible, to gain early evidence of efficacy, or any comparable trial under applicable Laws in the United States or the corresponding regulation in jurisdictions other than the United States.

Examples of Phase 1 Clinical Trial in a sentence

Allorion will transfer all responsibilities for the ongoing Phase 1 Clinical Trial with respect to the ARTS-021 Program in the U.S. (as further specified in Exhibit 8.1) to Avenzo promptly following the Effective Date.
As of such transfer and assignment, Avenzo will assume all obligations, responsibilities and liabilities with respect to the ongoing Phase 1 Clinical Trial from and after the date of such transfer and assignment and Allorion will have no further obligations, responsibilities, or liabilities with respect to the performance of such ongoing Phase 1 Clinical Trial from and after the date of such transfer and assignment.
For clarity, ▇▇▇▇▇▇▇▇ will be responsible for any and all liabilities to the extent based on or arising from the performance of such ongoing Phase 1 Clinical Trial by or on behalf of Allorion or its Affiliates prior to the date of such transfer and assignment.

More Definitions of Phase 1 Clinical Trial

Phase 1 Clinical Trial means a clinical development program in any country that generally provides for the first introduction into humans of a pharmaceutical product candidate with the primary purpose of which is preliminary determination of safety, metabolism and pharmacokinetic properties and clinical pharmacology of such pharmaceutical product candidate in healthy patients, or otherwise generally consistent with U.S. 21 C.F.R. §312.21(a).

Phase 1 Clinical Trial means a human clinical trial in any country that would satisfy the requirements of 21 CFR 312.21(a).

Phase 1 Clinical Trial means a human clinical trial of a Licensed Product that would satisfy the requirements of 21 CFR 312.21(a), regardless of whether such trial is referred to as a “phase 1 clinical trial” in the Development Plan.

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 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 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 human clinical trial that is intended to initially evaluate the safety and/or pharmacological effect of Licensed Product or that would otherwise satisfy the requirements of 21 C.F.R. 312.21(a) or an equivalent clinical trial in a country in the Territory other than the United States.