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NCT Number: NCT06714253

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

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.

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Key information

Conditions

Radiation-Induced Xerostomia and Hyposalivation Mouth Diseases Salivary Gland Diseases Stomatognathic Diseases Xerostomia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of Iowa Hospitals and Clinics, Iowa City, Iowa, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

*

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

Exclusion criteria

*

  • Any active infection
  • Heart failure, reduced kidney function or uncontrolled diabetes (Hemoglobin A1c >=8%)
  • History of autoimmune diseases known to potentially affect the salivary glands
  • Any malignancy, other than head and neck cancer within the past 3 years except for certain skin and cervical cancers
  • Active smoker or use tobacco products or have a history of substance or alcohol abuse
  • Other criteria apply

Treatment and study plan

RXRG001

Biological

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

Placebo

Biological

Placebo (saline)

Primary outcomes

  1. 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

  2. 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

Study contacts

Contact information is provided by the study sponsor or research team.

RiboX Therapeutics Ltd.

CONTACT

[email protected]

617-999-8257

Sponsors and collaborators

Lead sponsor

RiboX Therapeutics Ltd.

Industry

Registry information

Official study title

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

Acronym: SPRINX-1

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 3, 2024
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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