Phase Ib Trial definition

Phase Ib Trial means the clinical trial activities contemplated under the Post-Option Interim Development Plan or a clinical trial of a Product under this Agreement that: (a) follows completion of a Phase Ia Trial; (b) is for the purposes of establishing initial safety, tolerability, pharmacokinetic and pharmacodynamic and initial clinical effectiveness Information for the Product, (c) exposes subjects in the trial to repeated doses of the Product; and (d) is designed to provide the sponsor of the clinical trial with sufficient Information about the Product to initiate a Phase II Trial for the Product.
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Phase Ib Trial means a human clinical trial of a product, the principal purpose of which is a further determination of safety and pharmacokinetics of the compound in combination with concomitant treatment after an initial Phase Ia Trial, prior to Commencement of Phase II Trials or Phase III Trials, and which provides (itself or together with other available Data) sufficient evidence of safety to be included in filings for a Phase II Trial or a Phase III Trial with Regulatory Authorities, or a similar clinical study prescribed by the Regulatory Authorities in a foreign country.
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Phase Ib Trial means a Phase I Trial in a patient population with the indication under investigation.
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Examples of Phase Ib Trial in a sentence

  • By way of example, should the Milestone Event (B) (Declaration of the recommended Phase II Trial or Phase Ib Trial expansion cohort dose) occur prior to Milestone Event (A) (Dosing of the third patient in the first Phase I Trial for a Licensed Product) the Milestone Payment due upon occurrence of Milestone Event (A) of $[***] shall be due in addition to the Milestone Payment due upon occurrence of Milestone Event (B) of $[***].

  • In the event that the Post-Option Interim Development Plan actually conducted by Takeda does include a Phase Ib Trial in any Other Indication, the “Other Indication Milestones” which are designated with an “*” in the table set forth above shall be adjusted, with respect to only such Other Indication included in the Post-Option Interim Development Plan, as follows: [***]* [***] [***]* [***] [***]* [***] .

  • In the event that the Post-Option Interim Development Plan actually conducted by Takeda does not include a Phase Ib Trial in both Primary Indications, the “Second Primary Indication Milestones” in the table set forth above shall be replaced with the table set forth below.