Study of Circular RNA Treatment in Patients With Radiation Induced Xerostomia-1
Recruiting now · Phase 1/Phase 2 · Has a placebo group
Conditions studied: Radiation-Induced Xerostomia and Hyposalivation
In brief
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.
Key facts
- Study ID
- NCT06714253
- Run by
- RiboX Therapeutics Ltd.
- People needed
- 42
- Starts
- 2025-03-05
- Expected to finish
- 2027-08-01
- Last updated by the study team
- 2026-07-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States (enrolling)
- John Hopkins University, Sidney Kimmel Comprehensive Cancer Center — Baltimore, Maryland, United States (enrolling)
- NYU Langone Medical Center — New York, New York, United States (enrolling)
- Penn Medicine - Otorhinolaryngology - Head and Neck Surgery Perelman — Philadelphia, Pennsylvania, United States (enrolling)
Full record on ClinicalTrials.gov
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