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.

Inclusion Criteria*

1. At least 18 years of age
2. Free from recurrence of your cancer and never have had another form of cancer for at least 2 years
3. Suffering from xerostomia and/or hyposalivation and have xerostomia symptoms which were not resolved after treatment for at least 3 months
4. Both parotid glands on imaging examination

Exclusion Criteria*

1. Any active infection

2. Heart failure, reduced kidney function or uncontrolled diabetes (Hemoglobin A1c >=8%)

3. History of autoimmune diseases known to potentially affect the salivary glands

4. Any malignancy, other than head and neck cancer within the past 3 years except for certain skin and cervical cancers

5. Active smoker or use tobacco products or have a history of substance or alcohol abuse

   • Other criteria apply

Part 1 (Phase 1): single-arm open-label Part 2 (Phase2): randomized, double-blind, placebo-controlled, parallel-group