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RecruitingPhase 1/Phase 2

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

RiboX Therapeutics Ltd. · NCT06714253

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 1, Phase 2
Target enrollment
42
US sites recruiting
4
Study start
March 5, 2025
Record last updated
September 23, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: RXRG001; Placebo

Conditions: Radiation-Induced Xerostomia and Hyposalivation

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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

Recruiting US locations

  • University of Iowa Hospitals and Clinics

    Iowa City, IA 52242

    Site contact: Principal Investigator

  • John Hopkins University, Sidney Kimmel Comprehensive Cancer Center

    Baltimore, MD 21287

    Site contact: Principal Investigator

  • NYU Langone Medical Center

    New York, NY 10016-6402

    Site contact: Principal Investigator

  • Penn Medicine - Otorhinolaryngology - Head and Neck Surgery Perelman

    Philadelphia, PA 19104

    Site contact: Principal Investigator

Study contacts (from the official record)

  • RiboX Therapeutics Ltd. · 617-999-8257 · RiboX-SPRINX1-RX-RIX-CS101-Study-Mailbox@ribox-tx.com
All phase 1 studies in Iowa →
Study of Circular RNA Treatment in Patients With Radiation Induced… (NCT06714253) | Bored Studies