Insulin nasal spray: can it reach the brain?
NCT ID NCT05866367
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This early study aimed to see if insulin given as a nasal spray reaches the brain and spinal fluid. Only 2 healthy adults were enrolled before the study was stopped. Researchers planned to measure insulin levels in spinal fluid and blood at several time points after a single dose.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Regular insulin (Novolin-R) given as a nasal spray
- What this could lead to
- If successful, this could show that insulin nasal spray reaches the brain, supporting future research into memory and mood treatments.
- What could go wrong
- This was a very small, early-phase study that was terminated before completion. Results may not be reliable or generalizable.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
2 people
The number who actually took part.
- Started
-
Aug 2023
- Finished
-
Jun 2024
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 35 years
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Subject is between ≥18 and ≤ 35 years of age 2. Subject's body mass index is between \>=18.5 and \<=24.9 3. Subject must be proficient in speaking English to comply with instructions and measures for the study 4. Subject can provide written informed consent 5. Female subjects must have either: (1) a negative pregnancy test at the screening and treatment visits OR (2) be at least 2 years post-menopausal/surgically sterile. Exclusion Criteria: 1. Subject has medical history and/or clinically determined disorders: chronic sinusitis, previous nasal and/or oto-pharyngeal surgery and severe deviated septum and/or other anomalies. 2. Subject has history of any of the following: active and significant central nervous system, psychiatric illness, pulmonary, or cardiovascular disorders or any other clinically relevant abnormality that inclusion would pose a safety risk to the subject as determined by investigator 3. Subject has participated in a clinical trial investigation within 3 months of this study. 4. Subject has an insulin allergy 5. Subject has Insulin-dependent diabetes 6. Subject is pregnant or breast feeding 7. Contraindication to spinal tap or other safety factors that preclude lumbar puncture in the investigator's opinion
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
HealthPartners Neuroscience Center
Saint Paul, Minnesota, 55130, United States
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