Clinical Trial

Retrospective Kinetic Safety Evaluation of an Intravenous Micellar Excipient Platform

Not Yet Recruiting
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Record status
This record was last updated May 29, 2026 (before its estimated July 30, 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-05-20.
Trial Details
NCT Number NCT07609069
Lead Sponsor PICO IV, Inc.
Conditions Drug Related Side Effects and Adverse Reactions, Infusion Reactions
Enrollment 625 participants
Start Date 2026-05-21
Primary Completion 2026-07-30 (estimated)
Study Completion 2026-07-30 (estimated)
Updated on ClinicalTrials.gov 2026-05-29