NCT03901781

Study of ST266 Given by Intranasal Delivery in Glaucoma Suspect Subjects

A Dose-escalating Phase 1 Open-label Safety Study of ST266 Given by Non-invasive Intranasal Trans-cribriform Delivery in Glaucoma Suspect Subjects Without Evidence of Glaucomatous Damage.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Noveome Biotherapeutics, formerly Stemnion · Industry
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this trial is to assess the safety of ST266 given by non-invasive intranasal trans-cribriform delivery to glaucoma suspect subjects with ocular hypertension, optic nerve cupping, or family history of glaucoma.

Detailed description

This clinical trial is a dose escalating design in three (3) cohorts. In the first cohort, subjects will be treated with ST266 delivered using a non-invasive trans-cribriform intranasal delivery device daily for 14 days, in alternating single nostrils. If there are no SAEs and no pattern of concern in the AE's, the Investigator may proceed to the second cohort. In Cohort Two, subjects will be administered ST266 to each nostril daily for 14 days. As with the first cohort, if there are no safety concerns, the investigator may move on to the third cohort. In Cohort Three, subjects will be administered ST266 to each nostril daily for 28 days. All subjects will be followed for 12 months after the last dose of study drug. ST266 will be administered by a health care professional trained to deliver ST266 intranasally. No efficacy data will be collected.

Conditions

• Ocular Hypertension

Interventions

Type	Name	Description
COMBINATION_PRODUCT	ST266 via Intranasal Delivery	ST266 administered by non-invasive trans-cribriform intranasal delivery using the SipNose intranasal device.

Timeline

• Start date: 2019-10-23
• Primary completion: 2022-05-20
• Completion: 2022-05-20
• First posted: 2019-04-03
• Last updated: 2022-08-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study