Retrospective Kinetic Safety Evaluation of an Intravenous Micellar Excipient Platform

Starting soon

Conditions studied: Drug Related Side Effects and Adverse Reactions, Infusion Reactions

In brief

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.

Key facts

Study ID

NCT07609069

Run by

PICO IV, Inc.

People needed

625

Starts

2026-05-21

Expected to finish

2026-07-30

Last updated by the study team

2026-05-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• PICO IV Central Data Coordinating Center — Sacramento, California, United States

Full record on ClinicalTrials.gov

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