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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
42
Circular ribonucleic acid encoding human aquaporin 1 encapsulated in a lipid nanoparticle
Placebo (saline)
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
RECRUITINGJohn Hopkins University, Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States
RECRUITINGNYU Langone Medical Center
New York, New York, United States
RECRUITINGPenn Medicine - Otorhinolaryngology - Head and Neck Surgery Perelman
Philadelphia, Pennsylvania, United States
RECRUITINGIncidence of treatment-emergent adverse events
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
Incidence of treatment-emergent serious adverse events
Time frame: Part 1: up to 60 weeks, Part 2: up to 60 weeks
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