# 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

> **NCT04043104** · PHASE1 · COMPLETED · sponsor: **MeiraGTx UK II Ltd** · enrollment: 24 (actual)

## Conditions studied

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

## Interventions

- **DRUG:** AAV2hAQP1: 1 x 10^11 vg/gland (single gland)
- **DRUG:** AAV2hAQP1: 3 x 10^10 vg/gland (both glands)
- **DRUG:** AAV2hAQP1: 3 x 10^11 vg/gland (single gland)
- **DRUG:** AAV2hAQP1: 1 x 10^11 vg/gland (both glands)
- **DRUG:** AAV2hAQP1: 1 x 10^12 vg/gland (single gland)
- **DRUG:** AAV2hAQP1: 3 x 10^11 vg/gland (both glands)
- **DRUG:** AAV2hAQP1: 3 x 10^12 vg/gland (single gland)
- **DRUG:** AAV2hAQP1: 1 x 10^12 vg/gland (both glands)

## Key facts

- **NCT ID:** NCT04043104
- **Lead sponsor:** MeiraGTx UK II Ltd
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE1
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2019-06-30
- **Primary completion:** 2023-03-28
- **Final completion:** 2023-03-28
- **Target enrollment:** 24 (ACTUAL)
- **Last updated:** 2023-04-24


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT04043104

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration 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". Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/clinical/NCT04043104. Licensed CC0.

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