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
RiboX Therapeutics Ltd.
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 ne…
Interventions
- BiologicalRXRG001
Circular ribonucleic acid encoding human aquaporin 1 encapsulated in a lipid nanoparticle
- BiologicalPlacebo
Placebo (saline)
Locations (4)
- University of Iowa Hospitals and ClinicsIowa City, Iowa
- John Hopkins University, Sidney Kimmel Comprehensive Cancer CenterBaltimore, Maryland
- NYU Langone Medical CenterNew York, New York
- Penn Medicine - Otorhinolaryngology - Head and Neck Surgery PerelmanPhiladelphia, Pennsylvania