drugset / Trial / NCT06714253
Study of Circular RNA Treatment in Patients With Radiation Induced Xerostomia-1
RandomizedParallel-groupDouble-blindTreatment
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.
Timeline
- Start
- 2025-03-05
- Primary completion
- 2027-08
- Completion
- 2027-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | RXRG001 | Other / unclassified | — | Other |
Indications
No indication recorded.