Retrospective Kinetic Safety Evaluation of an Intravenous Micellar Excipient Platform
Public ClinicalTrials.gov record NCT07609069. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Retrospective, Multi-Center Observational Study Evaluating the Kinetic Safety and Tolerability of an Intravenous Micellar Excipient Platform in Clinical Practice
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT07609069
- Recruitment status
- Not yet recruiting
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 625 participants
Conditions and interventions
Interventions
- PIV-850 (850-picometer Dual-NCE Acidic Matrix) Drug
- Legacy Heterogeneous Payload (Micellar Vehicle) Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 20, 2026
- Primary completion
- Jul 29, 2026
- Completion
- Jul 29, 2026
- Last update posted
- May 28, 2026
2026
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| PICO IV Central Data Coordinating Center | Sacramento | California | 95811 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07609069, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 28, 2026 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07609069 live on ClinicalTrials.gov.