Phase Ib Study definition

Phase Ib Study means a human clinical trial of a product that (a) is for the purposes of establishing initial safety, tolerability, pharmacokinetic, pharmacodynamic and initial clinical effectiveness information of the product and (b) administers repeated doses of the product to subjects in the trial.
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Phase Ib Study means a study in healthy subjects (rather than patients in the proposed indication) with a primary endpoint of safety and tolerability and which has the additional purpose of investigating the pharmacokinetics, pharmacodynamics and preliminary·indications of efficacy of the Product.
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Phase Ib Study means a Phase I Study in patients assessing the safety and tolerability of the Compound ***.
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Examples of Phase Ib Study in a sentence

  • The initial Development Plan shall include an obligation for Provention to conduct a Phase Ib Study of the Product in patients for one or more Indications.

  • After the Option Trigger Date, Pfizer shall have the right from time to time to request additional efficacy and safety data from both the Phase Ib Study and the Phase IIa Study that was generated during the Option Period, and Lpath shall provide such information *** after such request.

  • Activities to wind down the Phase Ib Study will be conducted under the Development Plan, and costs therefor incurred under the Development Plan taken into account as Shared Costs.

  • During the Option Period, Lpath may, but shall not be obligated to, resume the Phase Ib Study or conduct a similar study outside of the Development Plan at Lpath’s expense (except with respect to costs for wind-down activities conducted under the Development Plan, which shall be Shared Expenses).

  • Phase Ib Study: two (2) step approach, consisting of: (a) fifteen (15) patients in ▇▇▇▇▇’▇ and ten (10) patients in AML; and (b) fifteen (15) additional patients in ▇▇▇▇▇’▇ and NO additional patients in AML.


More Definitions of Phase Ib Study

Phase Ib Study shall have the meaning set forth in Section 1.46.
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Phase Ib Study means the Phase Ib study of Sonepcizumab in pigment epithelial detachment referred to by Lpath as the PEDigree Study.
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Related to Phase Ib Study

  • Phase I Study means a human clinical trial in any country that would satisfy the requirements of 21 C.F.R. § 312.21(a) (FDCA), as amended from time to time, and the foreign equivalent thereof.

  • Phase II Study means a human clinical trial, for which the primary endpoints include a determination of dose ranges and/or a preliminary determination of efficacy in patients being studied as described in 21 C.F.R. § 312.21(b) (FDCA), as amended from time to time, and the foreign equivalent thereof.

  • Phase III Study means a human clinical trial that is prospectively designed to demonstrate statistically whether a product is safe and effective for use in humans in a manner sufficient to obtain regulatory approval to market such product in patients having the disease or condition being studied as described in 21 C.F.R. § 312.21(c) (FDCA), as amended from time to time, and the foreign equivalent thereof.

  • Phase 3 Study means a clinical study of a drug candidate in human patients that incorporates accepted endpoints for confirmation of statistical significance of efficacy and safety with the aim to obtain Regulatory Approval in any country as described in 21 C.F.R. 312.21(c), or a comparable clinical study prescribed by the relevant Regulatory Authority in a country other than the United States. The relevant drug candidate may be administered to patients as a single agent or in combination with other investigational or marketed agents.

  • Phase II Clinical Study means a human clinical study of a product initiated to determine the safety and efficacy in the target patient population, as described 21 C.F.R. 312.21(b).