Clinical Trial

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

Study acronym: SPRINX-1
Recruiting Phase 1/2
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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.
Protocol Amendment History 15 amendments
This ClinicalTrials.gov record has been amended 15 times since 2024-11-27; most recent amendment 2026-06-24.
Status change: Not Yet Recruiting → Recruiting 2025-03-06
Trial Details
NCT Number NCT06714253
Lead Sponsor RiboX Therapeutics Ltd.
Conditions Radiation-Induced Xerostomia and Hyposalivation
Enrollment 42 participants
Start Date 2025-03-05
Primary Completion 2027-08 (estimated)
Study Completion 2027-08 (estimated)
Updated on ClinicalTrials.gov 2026-07-29