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.
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Incidence of treatment-emergent adverse events
Timeframe: Part 1: up to 60 weeks, Part 2: up to 60 weeks
Incidence of treatment-emergent serious adverse events
Timeframe: Part 1: up to 60 weeks, Part 2: up to 60 weeks
RiboX Therapeutics Ltd.