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Retrospective Kinetic Safety Evaluation of an Intravenous Micellar Excipient Platform

NCT07609069 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 625

Last updated 2026-05-29

No results posted yet for this study

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.

Conditions

  • Drug Related Side Effects and Adverse Reactions
  • Infusion Reactions

Interventions

DRUG

PIV-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.

DRUG

Legacy 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.

Sponsors & Collaborators

  • PICO IV, Inc.

    lead INDUSTRY

Principal Investigators

  • Aimee Aquitania, Nurse Practitioner · Wellness Mobile Nursing SoCal Corporation

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-21
Primary Completion
2026-07-30
Completion
2026-07-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07609069 on ClinicalTrials.gov