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
This trial does not accept healthy volunteersQualifiers
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 population
The study population consists of a retrospective cohort of subjects who received (IV) infusions of the Sponsor's proprietary sub-nanometer micellar delivery platform (evaluating a legacy heterogeneous payload and the highly purified PIV-850 synthetic-equivalent dual-NCE matrix) within private medical clinics, specialty infusion centers, and outpatient practice settings across the United States. The sample is drawn from a diverse clinical population evaluated between June 1, 2025, and April 15, 2026. To ensure high-fidelity safety data and eliminate selection bias, the population is derived via a mandatory 100% consecutive sampling algorithm at each activated site. This cohort represents subjects receiving investigational micellar infusions for a range of legacy clinical observations in routine medical practice, utilizing exclusively single-use sterile vials to ensure alignment with pharmaceutical-grade Chemistry, Manufacturing, and Controls (CMC) sterile fill-finish standards.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
PIV-850 (850-picometer Dual-NCE Acidic Matrix)
DrugAn 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)
DrugA 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.
Treatment groups
625 Participants
are divided into 2 treatment groupsGroup A: Legacy Payload (Micellar Vehicle)1 intervention
Group B: PIV-850 Dual-NCE (Micellar Vehicle)1 intervention
Trial outcomes
Primary outcomes
1
Incidence and Severity of Infusion-Emergent Adverse Events (IEAEs)
Percentage of participants experiencing adverse events as documented in clinical charts. This includes specific monitoring for: 1) Infusion-Related Reactions: Complement Activation-Related Pseudoallergy (CARPA) symptoms such as facial flushing, dyspnea, tachycardia, or back/flank pain. 2) Vehicle Toxicity: Clinical signs of systemic intolerance to the Polysorbate 80-based micellar vehicle. Severity Grading: Events are systematically mapped and graded per the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 (Grades 1-5).
Time frame
From the initiation of the first intravenous infusion through 24 hours post-infusion.Secondary outcomes
1
Rate of Early Infusion Discontinuation Due to Intolerance
The percentage of participants who discontinued their intended course of IV infusions specifically due to an adverse event or intolerance to the micellar formulation.
Time frame
Duration of individual clinical exposure, up to 46 weeks.2
Maximum Observed Dose Tolerability
Documentation of the highest dose tier (measured in total milligrams of active small-molecule payload) administered to participants without the occurrence of a severe adverse event. Retrospective abstraction will capture extreme supratherapeutic exposures (including multi-vial administrations exceeding the standard single-vial volume) to establish the maximum kinetic safety ceiling of the micellar delivery vehicle, providing a definitive safety margin for future prospective clinical targets.
Time frame
Duration of individual clinical exposure, up to 46 weeks.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: