Study of Circular RNA Treatment in Patients With Radiation Induced Xerostomia-1
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorRiboX Therapeutics Ltd.
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
RXRG001
Biological/VaccineCircular ribonucleic acid encoding human aquaporin 1 encapsulated in a lipid nanoparticle
Placebo
Biological/VaccinePlacebo (saline)
Treatment groups
42 Participants
are divided into 3 treatment groupsGroup A: RXRG001 Part 1Experimental treatment 1 intervention
Group B: RXRG001 Part 2Experimental treatment 1 intervention
Group C: Placebo Part 2Placebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of treatment-emergent adverse events
Incidence of treatment-emergent adverse events
Time frame
Part 1: up to 60 weeks, Part 2: up to 60 weeks2
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 weeksSponsors and contacts
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Source ClinicalTrials.gov