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Retrospective Kinetic Safety Evaluation of an Intravenous Micellar Excipient Platform
Sponsor: PICO IV, Inc.
Summary
Protocol PICO-RWE-001: The goal of this observational study is to evaluate the kinetic safety and tolerability of an investigational intravenous micellar delivery platform. Researchers will abstract medical records of individuals who previously received this infusion in a clinical setting. The main questions the study aims to answer are: What adverse events (AEs) did participants experience during or after the infusion? Did participants discontinue their infusion regimen early due to adverse events? Researchers will abstract charts from clinical exposures occurring between June 1, 2025, and April 15, 2026. Participants do not undergo any new interventions or clinic visits.
Official title: Retrospective, Multi-Center Observational Study Evaluating the Kinetic Safety and Tolerability of an Intravenous Micellar Excipient Platform in Clinical Practice
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
625
Start Date
2026-05-21
Completion Date
2026-07-30
Last Updated
2026-05-29
Healthy Volunteers
No
Interventions
PIV-850 (850-picometer Dual-NCE Acidic Matrix)
An investigational, highly purified synthetic-equivalent New Chemical Entity (NCE) formulation comprising an acidic small-molecule complex, encapsulated in a proprietary 850-picometer hydrophilic micelle delivery system. Trace neutral byproducts generated during the thermal/ultrasonic manufacturing process are thermodynamically arrested within the micelle and classified strictly as inactive specified degradants (ICH Q3B limits). The formulation is engineered for intravenous (IV) administration via push or drip. This study observes the systemic safety, kinetic tolerability, and absence of Complement Activation-Related Pseudoallergy (CARPA) for this specific NCE profile in routine clinical practice.
Legacy Heterogeneous Payload (Micellar Vehicle)
A legacy iteration of the 850-picometer micellar delivery platform evaluating early kinetic safety thresholds. The Polysorbate 80 vehicle payload consisted of a broad heterogeneous precursor mixture. This formulation was administered intravenously (IV) via push or drip in clinical settings. Retrospective data abstracted from this cohort is utilized strictly to isolate the kinetic safety margin, thermodynamic stability, and tolerability of the delivery vehicle, entirely independent of the active payload.
Locations (1)
PICO IV Central Data Coordinating Center
Sacramento, California, United States