Gland Hypofunction and Xerostomia
common.study.values.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.
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participant.ui.study.affiliations-map.online-study.header-virtual
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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
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participant.views.study.view.scientific-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
common.study.values.clinical-trial-id
NCT04043104
participant.views.study.view.id
aQWp0d
