Retrospective, Multi-Center Observational Study Evaluating the Kinetic Safety and Tolerability of an Intravenous Micellar Excipient Platform in Clinical Practice
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.
Description
Detailed Description: Protocol PICO-RWE-001 I. SCIENTIFIC RATIONALE AND PLATFORM ARCHITECTURE Protocol PICO-RWE-001 is a retrospective, multi-center observational clinical investigation designed to establish the systemic safety and tolerability profile of a proprietary sub-nanometer micellar delivery platform. The platform utilizes a specialized 850-picometer hydrophilic emulsion, engineered to encapsulate lipophilic organic compounds (PIV-850 and legacy heterogeneous payloads) for intravenous administration. In biopharmaceutical development, particle size is a primary determinant of safety a…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Participant must have received at least one intravenous (IV) investigational exposure of the PICO IV 850-picometer micellar platform (evaluating either a legacy heterogeneous payload or the PIV-850 synthetic-equivalent dual-NCE matrix) between June 1, 2025, and April 15, 2026. * The investigational product administered must have been drawn exclusively from a Single-Use Sterile Vial. * The participant record must have been identified via a 100% consecutive sampling algorithm (15 to 25 patients per site) at the clinical site to eliminate selection bias. * Electronic Medica…
Interventions
- DrugPIV-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.
- DrugLegacy 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.
Location
- PICO IV Central Data Coordinating CenterSacramento, California