Phase 1a Clinical Trial definition

Phase 1a Clinical Trial means a human clinical trial of a compound, the principal purpose of which is a preliminary determination of safety, pharmacokinetics, and pharmacodynamic parameters in healthy individuals or patients, as described in 21 C.F.R. 312.21(a), or a similar clinical study prescribed by the Regulatory Authorities in a foreign country.

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Phase 1a Clinical Trial means a single ascending dose (“SAD”) Phase 1 Clinical Trial of a pharmaceutical product, the principal purpose of which is a preliminary determination of safety and pharmacokinetic parameters in healthy individuals.

Phase 1a Clinical Trial means a single dose or multiple dose ascending clinical trial intended to evaluate safety and tolerability and determination of dose(s) for further clinical evaluation; and

Examples of Phase 1a Clinical Trial in a sentence

• Molecular Partners shall be solely responsible for all Development Costs incurred by or on behalf of Molecular Partners or its Affiliates with respect to Development activities related to the Phase 1a Clinical Trial for the Licensed Bispecific.

• The first administration of a subject in a Phase 1a Clinical Trial of any Licensed Technology, Licensed Compound or Licensed Product.

• Reasonably prior to Molecular Partners’ Initiation of the Phase 1a Clinical Trial of the Combination Therapy, the Parties shall define and allocate each Party’s responsibilities with respect to pharmacovigilance activities for the Licensed Bispecific, Combination Therapies and MP Combination Therapies under a written agreement (the “Safety Agreement”).

• As Development Lead, Molecular Partners shall be responsible for oversight of all Development activities for the Licensed Bispecific, including responsibility for all preclinical Development, conducting IND-enabling activities, and conducting the Phase 1a Clinical Trial for the Licensed Bispecific, as more particularly set forth in the Development Plan.

• Upon completion of the Phase 1a Clinical Trial for the Licensed Bispecific (i.e., after the last patient has been dosed and generation of the report form for the Phase 1a Clinical Trial), the Parties shall initiate a process to transfer the Regulatory Lead role to Amgen as expeditiously as practicable.

• Molecular Partners, either itself or through a Third Party contract manufacturing organization (a “CMO”) reasonably acceptable to Amgen, shall supply pre-clinical and clinical quantities (for the Phase 1a Clinical Trial) of the Licensed Bispecific for the Development of the Licensed Bispecific in accordance with this Agreement, including out of any inventory of the Licensed Bispecific existing as of the Effective Date.

• Upon completion of the Phase 1a Clinical Trial for the Licensed Bispecific, the Parties shall initiate a process to transfer the Development Lead role to Amgen as expeditiously as practicable.

More Definitions of Phase 1a Clinical Trial

Phase 1a Clinical Trial means the Phase 1 Clinical Trial monotherapy dose escalation activities for the Licensed Bispecific, the principal purpose of which is a preliminary determination of safety, tolerability, or pharmacokinetics, as further defined in the Development Plan.

Phase 1a Clinical Trial means a human clinical trial of a product, the principal purpose of which is a preliminary determination of safety, pharmacokinetic, and pharmacodynamic parameters in healthy individuals or patients, or a similar clinical study prescribed by the Regulatory Authorities. “Phase 1B Clinical Trial” shall mean a human clinical trial of a product: (a) the principal purpose of which is to evaluate safety and tolerability of the drug following repeat dosing in patients and (b) the secondary purpose of which is to evaluate biomarker-based and clinical endpoint-based trends of efficacy, conducted after the initiation of an initial Phase 1 Clinical Trial or Phase 1A Clinical Trial of such product, prior to commencement of Phase 2 Clinical Trials or Phase 3 Clinical Trials, and that is designed to provide (itself or together with other available data) evidence of sufficient safety and clinical activity to enable the decision to proceed to a Phase 2 Clinical Trial, or any comparable trial as defined or referenced under applicable Laws. “Phase 2 Clinical Trial” means a human clinical trial of a product designed to satisfy the requirements of 21 C.F.R. § 312.21(b) and intended to explore a variety of doses, dose response, and duration of effect, and to generate data on side effects and clinical efficacy for a particular indication or indications in a target patient population, or any comparable trial under applicable Laws. “Phase 3 Clinical Trial” means a human clinical trial of a product designed to satisfy the requirements of 21 C.F.R. § 312.21(c) and is intended to (a) establish that the product is safe and efficacious for its intended use, (b) define contraindications, warnings, precautions and adverse reactions that are associated with the product in the dosage range to be prescribed, and (c) support Regulatory Approval for such product, or any comparable trial under applicable Laws. “Phase 4 Clinical Trial” means a human clinical trial, or other test or study, of a product for an indication that is commenced after receipt of the initial Regulatory Approval for such indication and that is conducted within the parameters of the Regulatory Approval for the product for such indication (and which may include investigator sponsored clinical trials), including a clinical trial conducted due to the request or requirement of a Regulatory Authority or as a condition of a previously granted Regulatory Approval. “Pre-Clinical Development” means activities reasonably relating t...