Retrospective Kinetic Safety Evaluation of an Intravenous Micellar Excipient Platform
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorPICO IV, Inc.
About this trial
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.
Eligibility criteria
Qualifiers
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 Medical Record (EMR) or clinic infusion logs must contain complete data regarding dosing, administration route (IV Push vs. IV Drip), and post-infusion safety observations.
Disqualifiers
Participants whose exposures were drawn from legacy multi-use vials.
Participants with exposures occurring outside the specific date window of June 1, 2025 - April 15, 2026.
Participants with incomplete clinical records where Infusion-Emergent Adverse Events (IEAEs) or safety outcomes were not documented.
Participants whose records were not identified chronologically backward from April 15, 2026.
Trial design
Treatments tested in this trial
- PIV-850 (850-picometer Dual-NCE Acidic Matrix)
- Legacy Heterogeneous Payload (Micellar Vehicle)
Treatment groups
625 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov