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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: MeiraGTx UK II Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Radiation-Induced Parotid Gland Hypofunction
• Xerostomia Due to Radiotherapy
• Head and Neck Cancer

Interventions

Type	Name	Description
DRUG	AAV2hAQP1: 1 x 10^11 vg/gland (single gland)	Intra-parotid administration of AAV2hAQP1 via Stensen's duct to a single parotid gland at a dose level of 1 x 10\^11 vg/gland
DRUG	AAV2hAQP1: 3 x 10^10 vg/gland (both glands)	Intra-parotid administration of AAV2hAQP1 via Stensen's duct to both parotid glands at a dose level of 3 x 10\^10 vg/gland
DRUG	AAV2hAQP1: 3 x 10^11 vg/gland (single gland)	Intra-parotid administration of AAV2hAQP1 of via Stensen's duct to a single parotid gland at a dose level of 3 x 10\^11 vg/gland
DRUG	AAV2hAQP1: 1 x 10^11 vg/gland (both glands)	intra-parotid administration of AAV2hAQP1 via Stensen's duct to both parotid glands at a dose level of 1 x 10\^11 vg/gland
DRUG	AAV2hAQP1: 1 x 10^12 vg/gland (single gland)	Intra-parotid administration of AAV2hAQP1 via Stensen's duct to a single parotid gland at a dose level of 1 x 10\^12 vg/gland
DRUG	AAV2hAQP1: 3 x 10^11 vg/gland (both glands)	Intra-parotid administration of AAV2hAQP1 via Stensen's duct to both parotid glands at a dose level of 3 x 10\^11 vg/gland
DRUG	AAV2hAQP1: 3 x 10^12 vg/gland (single gland)	Intra-parotid administration of AAV2hAQP1 via Stensen's duct to a single parotid gland at a dose level of 3 x 10\^12 vg/gland
DRUG	AAV2hAQP1: 1 x 10^12 vg/gland (both glands)	Intra-parotid administration of AAV2hAQP1 via Stensen's duct to both parotid glands at a dose level of 1 x 10\^12 vg/gland

Timeline

• Start date: 2019-06-30
• Primary completion: 2023-03-28
• Completion: 2023-03-28
• First posted: 2019-08-02
• Last updated: 2023-04-24

Locations

6 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study