Human Clinical Trial definition

Human Clinical Trial means any Phase ▇ ▇▇▇▇▇, ▇▇▇▇▇ ▇ ▇▇▇▇▇, ▇▇▇▇▇ ▇ Trial or Phase 4 Trial the subject of which includes a Test Product or Product.
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Human Clinical Trial means an implant-study in humans which, at the time of commencement of the study, is intended to generate data regarding the safety, efficacy, or both of a Licensed Product to support a regulatory marketing approval application. If Licensed Products are used in “compassionate use” implants, the fiftieth (50th) such implant shall be deemed, for purposes of this Attachment B1, as the commencement of a Human Clinical Trial.
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Human Clinical Trial means any clinical program, tested in humans, that has received permission by the United States Food and Drug Administration under an Investigational New Drug pathway.
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Examples of Human Clinical Trial in a sentence

  • In order to maintain the Exclusive NCE status of a particular Chemical Entity, the applicable Party must initiate (i.e., administration of the first dose to the first patient) a First in Human Clinical Trial with respect to such Chemical Entity within [***] of the date of the IND filing that caused such Chemical Entity to become an Exclusive NCE.

  • All Animal and Human Clinical Trial Data, Regulatory Agency Submissions, and Adverse Event Records.

  • Lian hereby agrees to use its best efforts to cause Nanobiotix to be named as an additional insured party on its Life Science Human Clinical Trial Liability Insurance between Shanghai LianBio Development Co., Ltd.

  • By: /s/ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇, President Date: June 2, 2006 Date: 6-02-06 Phase V - Human Clinical Trial / Phase VI - Marketing Approval Assumptions Investigational Plan CL-7000, Rev.

  • If the Party does not initiate such a First in Human Clinical Trial within such [***] period, then the applicable Chemical Entity shall cease to be an Exclusive NCE of such Party upon the expiration of such [***] period.


More Definitions of Human Clinical Trial

Human Clinical Trial means a human clinical trial of a pre-commercial or commercial product.
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Related to Human Clinical Trial

  • 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 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 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 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.

  • 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.