Study of Circular RNA Treatment in Patients With Radiation Induced Xerostomia-1
Start Date
3/5/2025
Completion Date
8/1/2027
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 Criteria
Age Range: 18 years to No maximum
Interventions
RXRG001
Placebo
Conditions
Locations
University of Iowa Hospitals and Clinics
Iowa City, Iowa 52242
United States
John Hopkins University, Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland 21287
United States
NYU Langone Medical Center
New York, New York 10016-6402
United States
Penn Medicine - Otorhinolaryngology - Head and Neck Surgery Perelman
Philadelphia, Pennsylvania 19104
United States