Phase I Studies definition

Phase I Studies means that portion of the U.S. Development --------------- Plan, ROW Development Plan or Development relating to each Collaboration Product which provides for the first introduction into humans of such Collaboration Product including small scale clinical studies conducted in normal volunteers or patients to obtain information on such Collaboration Product's safety, tolerability, pharmacological activity, pharmacokinetics, drug metabolism and mechanism of action, as well as early evidence of effectiveness, as more fully defined in 21 C.F.R. (S) 312.21(a).

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Phase I Studies means that portion of the clinical development program which provides for the first introduction into humans of a Product including small scale clinical studies conducted in normal volunteers or patients to get information on Product safety.

Phase I Studies means the first clinical studies conducted in human volunteers or patients (e.g. patients with Alzheimer’s Disease or another central nervous system disorder) to obtain preliminary information on a Product’s safety, tolerability, pharmacodynamic

Examples of Phase I Studies in a sentence

• For the supply of Products to be used in Clinical Phase I Studies with respect to any other Pre-IND Program, the Parties will on a Product-by-Product basis negotiate an amendment to the Early Clinical Supply Agreement in good faith, subject to Section 6.2, whereby CureVac shall Manufacture or have Manufactured such Product on Genmab’s behalf.

• MacroGenics shall lead any discussions between the Parties related to Quality Assurance Measures for clinical supply of the Licensed Compound Bulk Drug Substance and Licensed Compound Drug Product for Phase I Studies and Phase II Studies.

• No royalties shall be payable on Phase I Studies, Phase II Studies or Phase III Studies to obtain the initial approval of a Collaboration Product or Collaboration Product used in studies to obtain approval of a Second Indication.

• Roche shall have the right to conduct all Phase I Studies involving Roche Clinical Compounds or Roche Marketed Products in accordance with the Phase I Plans.

• Each Party shall maintain records of all Phase I Studies conducted under the Phase I Plans (or cause such records to be maintained) in sufficient detail and in good scientific manner as will properly reflect all work done and results achieved by or on behalf of such Party in the performance of activities under the Phase I Plans.

More Definitions of Phase I Studies

Phase I Studies means the first clinical studies conducted in human volunteers or patients (e.g. patients with hypertension or diabetes) to obtain preliminary information on a Product’s safety, tolerability, pharmacodynamic activity, pharmacokinetics, drug metabolism and mechanism of action, as well as early evidence of effectiveness if possible, with respect to (i) the United States, as more fully defined in 21 C.F.R. § 312.21(a), as may be amended; or (ii) the equivalent of such a clinical study for submission to the EMEA; or (iii) equivalent submission in such other country or jurisdiction.

Phase I Studies means that portion of the Development Plan or Development relating to each Alliance Product which provides for the first introduction into humans of such Alliance Product including small scale clinical studies conducted in normal volunteers to obtain information on such Alliance Product's safety, tolerability, pharmacological activity, pharmacokinetics, drug metabolism and mechanism of action, as well as early evidence of effectiveness.

Phase I Studies. As to a specific Licensed Product, one or more controlled and lawful studies in humans, the principal purpose of which is a preliminary determination of safety of the Licensed Product for its intended use in healthy individuals or patients to support its continued testing in similar clinical trials prescribed by the FDA or any relevant foreign regulatory authority.

Phase I Studies means a human clinical trial in any country that is intended to initially evaluate the safety and/or pharmacological effect of a NO-Enhanced ▇▇▇-2 Compound or Licensed Product in subjects or that would otherwise satisfy requirements of 21 CFR 312.21(a), or its foreign equivalent.

Phase I Studies means the initial introduction of the Product

Phase I Studies means the initial introduction of the Product --------------- into humans to determine its metabolism and pharmacologic actions in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness, as prescribed by applicable FDA regulations (or equivalent regulations of the FDA-equivalent regulatory authority in the Territory).

Phase I Studies means human safety studies aiming at generating sufficient safety data to allow initiation of full scale Phase II patient studies.