Recruiting
Phase 1
Phase 2

RXRG001

Sponsor:

RiboX Therapeutics Ltd.

Code:

NCT06714253

Conditions

Radiation-Induced Xerostomia and Hyposalivation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

RXRG001

Placebo

Study Details

Brief 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.

Conditions

Radiation-Induced Xerostomia and Hyposalivation

Study ID

NCT06714253

Start date

Mar 5, 2025

Status verified date

Aug, 2026

Completion date

Aug, 2027

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

42 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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)

experimental: RXRG001 Part 2

Randomized double-blind with 3 subsequent multiple dose cohorts. RXRG001 is administered intraductally in the salivary gland (bilateral)

placebo comparator: Placebo Part 2

Randomized double-blind with 3 subsequent multiple dose cohorts. Placebo is administered intraductally in the salivary gland (bilateral)

Interventions

RXRG001

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

Placebo

Placebo (saline)

Primary outcome measure

  • Incidence of treatment-emergent adverse events [ Time Frame: 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 ]

Central Contacts and Locations

Central contacts

RiboX Therapeutics Ltd.

617-999-8257RiboX-SPRINX1-RX-RIX-CS101-Study-Mailbox@ribox-tx.com

Locations

University of Iowa Hospitals and Clinics

Recruiting

Iowa City, Iowa, United States, 52242

John Hopkins University, Sidney Kimmel Comprehensive Cancer Center

Recruiting

Baltimore, Maryland, United States, 21287

NYU Langone Medical Center

Recruiting

New York, New York, United States, 10016-6402

Penn Medicine - Otorhinolaryngology - Head and Neck Surgery Perelman

Recruiting

Philadelphia, Pennsylvania, United States, 19104

More Information

Sponsor

RiboX Therapeutics Ltd.

Last update posted

Aug 26, 2026

Last verified

Aug, 2026

Keywords

  • Radiation Induced Xerostomia
  • First-in-human
  • Hyposalivation
  • Circular ribonucleic acid
  • Aquaporin 1

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by RiboX Therapeutics Ltd. on 2026-08-26.