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
Qualifiers
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
Treatments tested in this trial
- RXRG001
- Placebo
Treatment groups
42 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov