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

May 26, 2026 updated by: RiboX Therapeutics Ltd.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

42

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • University of Iowa Hospitals and Clinics
        • Contact:
          • Principal Investigator
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • John Hopkins University, Sidney Kimmel Comprehensive Cancer Center
        • Contact:
          • Principal Investigator
    • New York
      • New York, New York, United States, 10016-6402
        • Recruiting
        • NYU Langone Medical Center
        • Contact:
          • Principal Investigator
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Penn Medicine - Otorhinolaryngology - Head and Neck Surgery Perelman
        • Contact:
          • Principal Investigator

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria*

  1. At least 18 years of age
  2. Free from recurrence of your cancer and never have had another form of cancer for at least 2 years
  3. Suffering from xerostomia and/or hyposalivation and have xerostomia symptoms which were not resolved after treatment for at least 3 months
  4. Both parotid glands on imaging examination

Exclusion Criteria*

  1. Any active infection
  2. Heart failure, reduced kidney function or uncontrolled diabetes (Hemoglobin A1c >=8%)
  3. History of autoimmune diseases known to potentially affect the salivary glands
  4. Any malignancy, other than head and neck cancer within the past 3 years except for certain skin and cervical cancers

  5. Active smoker or use tobacco products or have a history of substance or alcohol abuse

    • Other criteria apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RXRG001 Part 1
Open-label, single arm with 6 subsequent dose cohorts (3 single dose and 3 multiple dose cohorts) of RXRG001 administered intraductally in the salivary gland (unilateral)
Biological: RXRG001
Circular ribonucleic acid encoding human aquaporin 1 encapsulated in a lipid nanoparticle
Experimental: RXRG001 Part 2
Randomized double-blind with 3 subsequent multiple dose cohorts. RXRG001 is administered intraductally in the salivary gland (bilateral)
Biological: RXRG001
Circular ribonucleic acid encoding human aquaporin 1 encapsulated in a lipid nanoparticle
Placebo Comparator: Placebo Part 2
Randomized double-blind with 3 subsequent multiple dose cohorts. Placebo is administered intraductally in the salivary gland (bilateral)
Biological: Placebo
Placebo (saline)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of treatment-emergent adverse events
Time Frame: Part 1: up to 60 weeks, Part 2: up to 60 weeks
Incidence of treatment-emergent adverse events
Part 1: up to 60 weeks, Part 2: up to 60 weeks
Incidence of treatment-emergent serious adverse events
Time Frame: Part 1: up to 60 weeks, Part 2: up to 60 weeks
Incidence of treatment-emergent serious adverse events
Part 1: up to 60 weeks, Part 2: up to 60 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RiboX Therapeutics Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 5, 2025

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2027

Study Registration Dates

First Submitted

October 14, 2024

First Submitted That Met QC Criteria

November 27, 2024

First Posted (Actual)

December 3, 2024

Study Record Updates

Last Update Posted (Actual)

May 27, 2026

Last Update Submitted That Met QC Criteria

May 26, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RX-RIX-CS101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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