Radiation-Induced Xerostomia and Hyposalivation
Conditions
Keywords
Radiation Induced Xerostomia, First-in-human, Hyposalivation, Circular ribonucleic acid, Aquaporin 1
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.
Interventions
BIOLOGICALRXRG001
Circular ribonucleic acid encoding human aquaporin 1 encapsulated in a lipid nanoparticle
BIOLOGICALPlacebo
Placebo (saline)
Sponsors
RiboX Therapeutics Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Part 1 (Phase 1): single-arm open-label Part 2 (Phase2): randomized, double-blind, placebo-controlled, parallel-group
Intervention model description
Part 1 (Phase 1): single-arm, open-label Part 2 (Phase 2): randomized, double-blind, placebo-controlled, parallel-group
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of treatment-emergent adverse events | Part 1: up to 60 weeks, Part 2: up to 60 weeks | Incidence of treatment-emergent adverse events |
| Incidence of treatment-emergent serious adverse events | Part 1: up to 60 weeks, Part 2: up to 60 weeks | Incidence of treatment-emergent serious adverse events |
Countries
United States
Contacts
CONTACTRiboX Therapeutics Ltd.
Outcome results
None listed