Phase I Clinical Trial

Phase I Clinical Trial. A human clinical trial in any country that is intended to initially evaluate the of a product in subjects or that would otherwise satisfy the requirements of 21 CFR 312.21(a) or its foreign equivalent

Phase I Clinical Trial. As to a particular product for a particular indication, the initial study in humans of the safety of such product for such indication, which is prospectively designed to generate data to support commencing a Phase II Clinical Trial (as defined in the License Option Agreement) of such product for such indication.

Phase I Clinical Trial. Any human clinical trial, conducted by or on behalf of Licensee, any of its Affiliates, or a Sublicensee with respect to a Covered Product, including typically the first phase of clinical trials conducted in relatively small numbers of healthy volunteers or patients with the targeted condition to obtain information on a Covered Product's safety, tolerability, pharmacological activity, pharmacokinetics, drug metabolism and mechanism of action, as more fully defined in 21 C.F.R. § 312.21(a), as... may be amended, and, with respect to any other country or jurisdiction, the equivalent of such a clinical trial in such other country or jurisdiction. View More

Phase I Clinical Trial. Means, with respect to a clinical trial conducted pursuant to an IND, any controlled human clinical trial conducted in the United States as required under and pursuant to 21 C.F.R. §312.21(a) and subject to the general oversight of the FDA, or, with respect to a jurisdiction other than the United States, a similar clinical study subject to the general oversight of the applicable Regulatory Authority.

Phase I Clinical Trial. Shall have the meaning ascribed by the FDA and as promulgated under 21 C.F.R. § 312.21(a).

Phase I Clinical Trial. The term "Phase I Clinical Trial" shall mean those further and lawful studies of a Product conducted anywhere in the Territory that the applicable Regulatory Authority requires to be performed on a sufficient number of healthy human patients to generate sufficient data to establish the safety and biological activity of that Product, and to permit commencement of a Phase II Clinical Trial.

Phase I Clinical Trial. The term "Phase I Clinical Trial" means a human clinical trial for any Product in any country that would satisfy the requirements of 21 CFR 312.21(a).

Phase I Clinical Trial. Means a human clinical trial in any country conducted by Company or its Affiliate to initially evaluate the safety of a Licensed Product in human subjects or that would otherwise satisfy the requirements of 21 CFR 312.21 (a) or the equivalent laws, rules or regulations in a regulatory jurisdiction outside the United States.

Phase I Clinical Trial. As to a specific Licensed Product, a study in humans of such product designed to satisfy the requirements of 21 C.F.R. § 312.21(a), as amended from time to time, or the corresponding regulation in jurisdictions other than the United States. A Phase I Clinical Trial shall be deemed initiated upon the first dosing of the first research subject.

Phase I Clinical Trial. A human clinical trial, in any country, that would satisfy the requirements of 21 C.F.R. 312.21(a).