University of Arizona #L342607

Phase 1 Clinical Trials for Investigational Drug PNA5 (SAD/MAD) in Healthy Volunteers

This opportunity from the University of Arizona seeks a qualified Contract Research Organization (CRO) to conduct Phase 1 clinical trials for the investigational drug PNA5. - Government Buyer: - Arizona Board of Regents, University of Arizona, College of Medicine, Departments of Physiology and Psychology - Key contacts: Rocio Torres and Meredith Hay, Ph.D. - OEMs and Vendors: - PNA5 is manufactured and supplied by the University of Arizona - Bioanalytical labs (MZBio and NorthEast Bio) are designated for sample analysis but excluded from this RFP - Products/Services Requested: - Primary product: PNA5 (synthetic glycopeptide derivative of Angiotensin-(1-7), immediate-release subcutaneous formulation) - Part number: PNA5 - Quantities: 40 for SAD protocol, 24 for MAD protocol - Matching placebo (vehicle), supplied by University of Arizona - Full-service Phase 1 clinical trial conduct (SAD/MAD) including: - Healthy volunteer recruitment, screening, dosing, discharge - Regulatory and ethics support, drug accountability, sample logistics - Biological sample collection, processing, storage, and shipment to designated labs - Safety monitoring, pharmacovigilance, clinical data management, biostatistics, medical writing, project management - Unique/Notable Requirements: - CRO must operate an in-house U.S. Phase 1 unit with advanced cardiac life support - Experience with first-in-human (FIH) SAD/MAD studies and intensive early PK sampling - 21 CFR Part 11-compliant systems and documented quality/GCP program - Milestone-based contracting and invoicing across multiple NIH budget periods - Flexibility for sponsor-directed pauses, delays, accelerations, and optional cohorts - Drug and placebo supplied by University; sample analysis by designated labs (excluded from RFP) - Study protocols and deliverables detailed in attached documents for both SAD and MAD arms

Description

The University of Arizona, represented by the Arizona Board of Regents, is soliciting proposals from qualified contract research organizations (CROs) to conduct Phase 1 clinical trials. The trials involve a first-in-human, randomized, double-blind, placebo-controlled single ascending dose (SAD) and multiple ascending dose (MAD) study of the investigational drug PNA5 in healthy adult volunteers. The study supports the development of a therapy for vascular contributions to cognitive impairment and dementia (VCID) and is funded under a multi-year NIH cooperative agreement. The selected vendor must support milestone-based contracting and invoicing across multiple NIH budget periods.

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