NCT05062785

Dose-Finding Study of Intranasal Insulin in Healthy Participants Insulin in Healthy Participants

Phase 1, Open Label Dose-Finding Study of Intranasal Insulin in Healthy Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Robert Silbergleit · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study is to determine the safety and tolerability of regular insulin (Humulin R) when given intranasally (as drops in nostrils). Healthy participants will be enrolled to determine the maximum tolerated dose of intranasal insulin.

Detailed description

This is being studied because intranasal insulin may be a way to prevent the brain injury that occurs after a cardiac arrest. Cardiac arrest is a life-threatening condition in which the heart suddenly stops beating and there is no blood flow to the body. If cardiac arrest is not treated immediately, it causes sudden death. Even when immediate treatment gets the heart beating again, many victims remain comatose and die later from brain injury. Nasal insulin, given immediately after a cardiac arrest may prevent or reduce brain injury. Nasal insulin reduces brain injury in animal experiments, and has been used to try to improve brain degeneration in patients with Alzheimer's disease. However, cardiac arrest patients may need higher doses than patients with Alzheimer's disease, therefore, this study is to examine those higher doses.

Conditions

• Out-Of-Hospital Cardiac Arrest
• Healthy

Interventions

Type	Name	Description
DRUG	Intranasal insulin	This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits. On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period participants will receive the initial dose of insulin squirted in each nostril followed by a a 4 hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits.

Timeline

• Start date: 2021-10-04
• Primary completion: 2022-04-25
• Completion: 2022-04-25
• First posted: 2021-09-30
• Last updated: 2026-03-27
• Results posted: 2026-03-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study