RecruitingPhase 1Phase 2NCT06714253

Study of Circular RNA Treatment in Patients With Radiation Induced Xerostomia-1

A Phase I/IIa, Dose Escalation Study Evaluating the Safety, Tolerability, and Preliminary Efficacy of Intraductal Administration of RXRG001 to Parotid Gland(s) in Adults With Radiation-Induced Xerostomia and Hyposalivation


Sponsor

RiboX Therapeutics Ltd.

Enrollment

42 participants

Start Date

Mar 5, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This is a first-in-human clinical study to evaluate the safety, tolerability and efficacy of RXRG001 administered in the ducts of the parotid glands in adult patients with radiation-induced xerostomia (dry mouth) and hyposalivation (reduced saliva production). In Part 1 of the study (open-label, single-arm), patients will receive unilateral administrations of RXRG001 in 3 single ascending dose cohorts and in 3 multiple ascending dose cohorts. Part 2 of the study has a randomized, double-blind, placebo-controlled design. Patients will receive bilateral administrations of RXRG001 in 3 multiple ascending dose cohorts.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called Placebo and a biological treatment called RXRG001 for people with radiation-induced xerostomia and hyposalivation. The study is currently recruiting participants at 4 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BIOLOGICALRXRG001

Circular ribonucleic acid encoding human aquaporin 1 encapsulated in a lipid nanoparticle

BIOLOGICALPlacebo

Placebo (saline)


Locations(4)

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

John Hopkins University, Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, United States

NYU Langone Medical Center

New York, New York, United States

Penn Medicine - Otorhinolaryngology - Head and Neck Surgery Perelman

Philadelphia, Pennsylvania, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06714253