drugset / Trial / NCT04043104
A Phase 1 Open-Label, Dose Escalation Study to Determine the Optimal Dose, Safety, and Activity of AAV2hAQP1 in Subjects With Radiation-Induced Parotid Gland Hypofunction and Xerostomia
Non-randomizedSequentialOpen-labelTreatment
Summary
Open-label, non-randomized, dose escalation trial of AAV2hAQP1 administered via Stensen's duct to a single or both parotid glands in subjects with radiation-induced xerostomia The objectives are to evaluate the safety and identify either a maximum tolerated dose or a maximum feasible dose of a single dose of AAV2hAQP1 infused into one or both parotid glands: To evaluate subject improvement of xerostomia symptoms, to evaluate the increase in parotid gland salivary output after treatment with AAV2hAQP1, to evaluate additional efficacy outcomes.
Timeline
- Start
- 2019-06-30
- Primary completion
- 2023-03-28
- Completion
- 2023-03-28
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | AAV2hAQP1 | Gene therapy (AAV / viral vector) | 3e+10 vg | Other |
| Subject | AAV2hAQP1 | Gene therapy (AAV / viral vector) | 1e+11 vg | Other |
| Subject | AAV2hAQP1 | Gene therapy (AAV / viral vector) | 3e+11 vg | Other |
| Subject | AAV2hAQP1 | Gene therapy (AAV / viral vector) | 1e+12 vg | Other |
| Subject | AAV2hAQP1 | Gene therapy (AAV / viral vector) | 3e+12 vg | Other |