MedTrace Logo

Safety Evaluation Study of Pitavastatin PLGA Nano-particle for Retinitis Pigmentosa

NCT07774975 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2026-08-19

No results posted yet for this study

Summary

Retinitis pigmentosa (RP) is a rare inherited retinal degenerative disease that causes progressive visual field loss and vision impairment, often leading to blindness. Currently, there are limited treatment options capable of slowing disease progression for the majority of patients with RP. Preclinical studies have suggested that retinal inflammation, particularly the activity of inflammatory monocytes and macrophages, may contribute to photoreceptor degeneration. ULREA-PVS-NP is a novel intravenous formulation consisting of pitavastatin encapsulated in poly(lactic-co-glycolic acid) (PLGA) nanoparticles, developed to target inflammatory pathways associated with retinal degeneration. Preclinical studies demonstrated suppression of inflammatory monocyte/macrophage activity and preservation of photoreceptors in animal models of RP.

This is a single-center, open-label, investigator-initiated Phase 1 study designed to evaluate the safety of intravenous ULREA-PVS-NP in adults with RP. The study consists of two parts. In Part 1, participants will receive a single intravenous infusion of ULREA-PVS-NP at escalating dose levels (2 mg, 4 mg, or 8 mg) to evaluate safety and tolerability. Following review of safety data, Part 2 will evaluate repeated administration of the highest dose considered safe in Part 1, given once every four weeks for a total of three administrations.

The primary objective is to evaluate the safety of ULREA-PVS-NP by assessing the incidence of adverse events. Secondary objectives include characterization of pharmacokinetic profiles, evaluation of changes in clinical laboratory tests and vital signs, and exploratory assessment of ophthalmologic outcomes and inflammatory biomarkers.

Conditions

  • Retinitis Pigmentosa (RP)

Interventions

DRUG

ULREA-PVS-NP

ULREA-PVS-NP is a poly(lactic-co-glycolic acid) (PLGA) nanoparticle formulation containing pitavastatin and administered intravenously. Part 1 is a single ascending-dose study in which participants receive a single intravenous administration of ULREA-PVS-NP at dose levels equivalent to 2 mg, 4 mg, or 8 mg of pitavastatin. Part 2 is a multiple-dose study in which participants receive repeated intravenous administrations at the highest dose level shown to be safe in Part 1.

Sponsors & Collaborators

  • Kyushu University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-15
Primary Completion
2028-01-31
Completion
2028-03-31

More Related Trials

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 NCT07774975 on ClinicalTrials.gov