Clinical Trial

Gland Hypofunction and Xerostomia

Study Description

A Phase 1/2 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

Open-label, non-randomized, dose escalation trial of AAV2hAQP1 administered via Stensen's duct to a single parotid gland 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 targeted parotid gland: 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.

Location

Locations Selected Location

Methods

Pharmaceutical medication involved Pharmaceutical medication involved
Recruiting patients only Recruiting patients only

Drug - intra-parotid administration of AAV2hAQP1

Open-label, non-randomized, dose escalation trial of AAV2hAQP1 administered via Stensen's duct to a single parotid gland in subjects with radiation-induced xerostomia. Dose levels: 1 x 1011 vg/mL* 3 x 1011 vg/mL 1 x 1012 vg/mL 3 x 1012 vg/mL 6 x 1012 vg/mL If 2 subjects experience a dose-limiting toxicity at the 1 x 1011 vg/mL dose level (Dose Group 1), then a lower dose of 3 x 1010 vg/mL may be studied. The total volume to be administered is subject specific, based on the subject's parotid glan ...read more on ClinicalTrials.org

Additional Information

Official Study Title

A Phase 1/2 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

Clinical Trial ID

NCT04043104

ParticipAid ID

aQWp0d