Retrospective Kinetic Safety Evaluation of an Intravenous Micellar Excipient Platform

Part of paid clinical trials in Sacramento, California.

Sponsor
PICO IV, Inc.
Study ID
NCT07609069
Status
Not Yet Recruiting

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Conditions

  • Drug Related Side Effects and Adverse Reactions
  • Infusion Reactions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • PIV-850 (850-picometer Dual-NCE Acidic Matrix) — DRUG
    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.
  • Legacy Heterogeneous Payload (Micellar Vehicle) — DRUG
    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.

Study Details

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 Dates

Start date
May 21, 2026
Status verified
May 2026
Primary completion
Jul 30, 2026
Completion
Jul 30, 2026

Study Design

Enrollment
625 participants (estimated)

Arms

  • Arm: Legacy Payload (Micellar Vehicle)
    Participants who received intravenous infusions of the 850-picometer Polysorbate 80 micellar excipient vehicle carrying a legacy heterogeneous payload in a clinical setting between June 1, 2025, and April 15, 2026.
  • Arm: PIV-850 Dual-NCE (Micellar Vehicle)
    Participants who received intravenous infusions of the 850-picometer Polysorbate 80 micellar excipient vehicle carrying the highly purified PIV-850 synthetic-equivalent dual-API NCE matrix in a clinical setting between June 1, 2025, and April 15, 2026.

Primary Outcome Measure

Incidence and Severity of Infusion-Emergent Adverse Events (IEAEs) [ Time Frame: From the initiation of the first intravenous infusion through 24 hours post-infusion. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
PICO IV Central Data Coordinating CenterSacramentoCalifornia95811-

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PICO IV Central Data Coordinating Center· Sacramento, CA

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