Phase IIb definition

Phase IIb means a Phase II study in any country, the principal purpose of which is to explore the dose relationship of a Product against some efficacy measure for the Indication in patients with the disease or Indication under study.

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Phase IIb means such studies in humans of the safety, dose ranging and efficacy of a Product designed to generate sufficient data to make a decision about whether to commence a Pivotal Trial, as more specifically defined by the rules and regulations of the FDA and corresponding rules and regulations in other countries or jurisdictions.

Phase IIb means a Phase II designed to support and immediately precede the initiation of a Phase III without any further Phase II, on a sufficient number of patients that is designed to provide a preliminary determination of safety and efficacy of the applicable Product or New Collaboration Compound in the target patient population over a range of dose and dose regimes.

Examples of Phase IIb in a sentence

• Reimbursement of such pre-Effective Date expenses shall be due within thirty (30) days after the first patient is dosed in the first Phase IIb Clinical Study for rheumatoid arthritis using such Clinical Study Supplies.

• For example, if a Phase IIb Clinical Trial is initiated without payment of the Successful Completion of Phase Clinical Study, then the Successful Completion of Phase Ib/IIa Clinical Study will be deemed to have occurred and will be paid in full upon payment of the milestone payable upon the submission of the first NDA filing.

• NTI shall inform Merz and CMCC on a regular basis about all such research and development work, including, but not limited to, Phase IIb clinical studies and ACTG studies, and Merz reserves the right to supervise any such further research and development as Merz reasonably deems necessary.

• With respect to any Product that is subject to Joint Development pursuant to Section 5.4(c) above, the JDC for such Product Candidate shall discuss and determine whether the Product Candidate is ready for Phase IIb Clinical Studies, and if not, what additional Development activities are required prior to the conduct of a Phase IIb Clinical Study.

• The Participating Phase IIb Party under a Unilateral Phase IIb Plan shall have the right to amend such Unilateral Phase IIb Plan, exercising reasonable good faith judgment consistent with the Principles, subject to the applicable JDC’s review and comment; provided that the Participating Phase IIb Party shall not have the right to make any such Unilateral Material Amendment without the other Party’s consent.

More Definitions of Phase IIb

Phase IIb means a Phase II clinical trial in human patients, the primary objective of which is to collect data on dosages and demonstrate clinical safety and efficacy in a target population for a specific disease or condition under study with a demonstration of efficacy (i.e. statistically significant differences between groups for clinical endpoints considered as a basis for registration, which may include generally accepted surrogate pharmacodynamic endpoints).

Phase IIb means a placebo or active drug controlled, randomized human clinical trial performed to gain evidence of the efficacy of a pharmaceutical product in a target population, and/or to establish the optimal dosing regimen for such product.

Phase IIb means a human clinical trial of a Licensed Compound or Licensed Product, the principal purpose of which is a determination of safety and appropriate dose-ranges for efficacy in the target patient population, which is prospectively designed to generate sufficient data that may permit commencement of pivotal clinical trials, or a similar clinical study prescribed by the Regulatory Authorities, from time to time, pursuant to Applicable Law or otherwise, including the trials referred to in 21 C.F.R. §312.21(b), as amended.

Phase IIb means human clinical trials, for which the primary endpoints include a determination of dose ranges, if not already determined, and a preliminary determination of efficacy in patients with the Indication being studied as required in 21 C.F.R. §312.21, or similar clinical study in a country other than the United States which design is intended to enable the Initiation of the Phase III or Pivotal clinical trial. 35. “Phase III” or “Pivotal” shall mean human clinical trials, the principal purpose of which is to establish safety and efficacy of one or more particular doses in patients with the Indication being studied in a manner designed to be sufficient to support Marketing Approval for such Indication, as required in 21 C.F.R. §312.21(c), or similar clinical study in a country other than the United States. For purposes of clarity, in the event that a Phase IIb has not already occurred with respect to the Indication being studied, upon the Initiation of a Phase III or Pivotal clinical trial, such clinical trial shall also be considered the Initiation of a Phase IIb clinical trial. 36. “Preexisting Third Party Intellectual Property” shall mean any intellectual property rights, including without limitation all patents, trademarks, copyrights, and any applications therefor, including any applications for registration, issuance, or grant thereof, that are owned or Controlled by a third party and that are necessary for the practice of the license granted hereunder, the existence of which was discoverable or otherwise could have been known on or prior to the Effective Date and were not owned or Controlled by FibroGen as of the Effective Date. 37. “Product” or “Products” shall mean any HIF Compound designated by FibroGen for clinical development in an Anemia Indication in accordance with the terms herein. As of the Effective Date, each of FG-2216 and FG-4592 shall be deemed to be a Product. For the avoidance of doubt, Product shall include the finished form of a pharmaceutical product containing such a HIF Compound described above, whether or not other ingredients (active or otherwise) are contained in such product.

Phase IIb. Start: May 1999 Ethics: June 1999 Recruitment : January 2000 Analysis: August 2000 Finish: September 2000 Phase III Start: September 2000 Finish: September 2003

Phase IIb. Proof of Process and production of validation batches

Phase IIb means a Phase II clinical trial in human patients, the primary objective of which is to collect data on dosages and demonstrate clinical safety and efficacy in a target population for a specific disease or condition [***] Certain information in this document has been omitted and submitted separately to the Securities and Exchange Commission. Confidential treatment has been requested separately with respect to the omitted portions. under study with a demonstration of efficacy (i.e. statistically significant differences between groups for clinical endpoints considered as a basis for registration, which may include generally accepted surrogate pharmacodynamic endpoints).