Study of Circular RNA Treatment in Patients With Radiation Induced Xerostomia-1

Condition(s) studied

Investigational drug(s) / intervention(s)

RXRG001: Circular ribonucleic acid encoding human aquaporin 1 encapsulated in a lipid nanoparticle

Placebo: Placebo (saline)

Study 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.

Eligibility

Primary outcome measure(s)

• 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

Trial sites (5)