HealthyPhase 1INI-CSFNCT05866367
Measurement of Insulin Levels in Cerebral Spinal Fluid (CSF) of Healthy Adults After a Single Intranasal Dose
A Phase 1 study testing Low dose Regular Insulin and High dose Regular insulin in people with Healthy, run by HealthPartners Institute at 1 site in United States.
Trial summary
The purpose of this study is to find out whether insulin, a drug approved by the FDA for the treatment of diabetes mellitus, reaches the brain and spinal cord when delivered as a nasal spray (intranasally). Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Low dose Regular Insulin and High dose Regular insulin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Aug 2023to 28 Jun 2024
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject is between ≥18 and ≤ 35 years of age
- Subject's body mass index is between >=18.5 and <=24.9
- Subject must be proficient in speaking English to comply with instructions and measures for the study
- Subject can provide written informed consent
- 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.
Who cannot join
- 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.
- 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
- Subject has participated in a clinical trial investigation within 3 months of this study.
- Subject has an insulin allergy
- Subject has Insulin-dependent diabetes
- Subject is pregnant or breast feeding
- Contraindication to spinal tap or other safety factors that preclude lumbar puncture in the investigator's opinion
Trial locations and contacts
1 site in 1 country.
United States1 site
HealthPartners Neuroscience Center
Saint Paul, Minnesota, 55130
About this study
The purpose of this study is to find out whether insulin, a drug approved by the FDA for the treatment of diabetes mellitus, reaches the brain and spinal cord when delivered as a nasal spray (intranasally). Intranasal insulin has been shown to improve memory and mood in patients with mild cognitive impairment and dementia, but more evidence is needed to support the ability to effectively target the brain through intranasal routes.
12 healthy adults will be randomly assigned to receive a single dose of either 40 units ("low dose" group) or 80 units ("high dose" group) of insulin. Participants will undergo image-guided lumbar puncture (spinal tap) performed by a study radiologist. Samples of cerebrospinal fluid (a fluid surrounding the brain and spinal cord) and blood will be collected at 5 timepoints during the lumbar puncture: once prior to the administration of intranasal insulin, and again at 10, 20, 30, and 40 minutes after the dose is given. Samples will be tested to determine the level of insulin detected in the cerebrospinal fluid and blood at each time point. Results of this study will provide essential information about the ability of the SipNose device to effectively deliver insulin to the central nervous system of humans as measured in the cerebrospinal fluid.
- Conditions
- Healthy
- Being tested
- Low dose Regular Insulin, High dose Regular insulin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low dose Regular InsulinDrug
Also called Novolin-R
Regular insulin administered intranasally at either 40 IU
High dose Regular insulinDrug
Also called Novolin-R
Regular insulin administered intranasally at either 80 IU
| Study group | Role | What they receive |
|---|---|---|
| Low dose Intranasal Insulin | Experimental | One dose of 40 international units of regular insulin administered intranasally using the SipNose SP1N1C1 device. Receives: Drug: Low dose Regular Insulin |
| High dose Intranasal Insulin | Experimental | One dose of 80 international units of regular insulin administered intranasally using the SipNose SP1N1C1 device. Receives: Drug: High dose Regular insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin Concentration Over Time - Cerebrospinal Fluid
Insulin concentration detected in cerebrospinal fluid at 5 time points (pre-insulin dose; and 10, 20, 30 ,40 minutes after dose). Values will be reported as μIU/mL. Higher values indicate a greater concentration of insulin in the cerebrospinal fluid. Concentrations for each time point (overall and by dose) will be reported as a mean +/- standard deviation. The limit of detection of the assay was 0.15mU/L (0.0065µg/L).
Measured: 0-40 minutes post-intranasal administration
Cmax of Insulin Concentration - Cerebrospinal Fluid
CSF insulin concentration will also be reported by Cmax (peak concentration)
Measured: 0-40 minutes post-intranasal administration
Tmax of Insulin Concentration - Cerebrospinal Fluid
CSF insulin concentration will also be reported by Tmax (time of peak concentration)
Measured: 0-40 minutes post-intranasal administration
AUC (Area Under the Curve) of Insulin Concentration - Cerebrospinal Fluid
CSF insulin concentration will also be reported by AUC (area under the curve, measured as time x concentration).
Measured: 0-40 minutes post-intranasal administration
Secondary outcomes (4)
Insulin Concentration Over Time - Serum
Insulin concentration detected in blood at 5 time points (pre-insulin dose; and 10, 20, 30 ,40 minutes after dose). Values will be reported as μIU/mL. Higher values indicate a greater concentration of insulin in the blood. Concentrations for each time point (overall and by dose) will be reported as a mean +/- standard deviation. Serum insulin concentration will also be reported by Cmax (peak concentration), Tmax (time of peak concentration), and AUC (area under the curve, measured as time x concentration).
Measured: 0-40 minutes post-intranasal administration
Cmax of Insulin Concentration - Serum
Serum insulin concentration will also be reported by Cmax (peak concentration).
Measured: 0-40 minutes post-intranasal administration
Tmax of Insulin Concentration - Serum
Serum insulin concentration will also be reported by Tmax (time of peak concentration).
Measured: 0-40 minutes post-intranasal administration
AUC (Area Under the Curve) of Insulin Concentration - Serum
Serum insulin concentration will also be reported by AUC (area under the curve, measured as time x concentration).
Measured: 0-40 minutes post-intranasal administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2023
- Study start16 Aug 2023
- Primary completion28 Jun 2024
- Study completion28 Jun 2024
Why it stopped: We are closing this clinical protocol due to supply chain issues. We are no longer able to obtain the intranasal delivery device. We do not have adequate funding available to continue with an alternative intranasal delivery device.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- HealthPartners Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leah R Hanson, PhD, Principal investigator, HealthPartners Neuroscience Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05866367
- Sponsor's protocol ID
- A21-299
- Acronym
- INI-CSF
- Status last verified
- Nov 2025
- First submitted
- 5 May 2023
- Last updated
- 18 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Insulin Levels in Cerebral Spinal Fluid (CSF) of Healthy Adults After a Single Intranasal Dose
- ClinicalTrials.gov ID
- NCT05866367
- Acronym / sponsor ID
- INI-CSF / A21-299
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: We are closing this clinical protocol due to supply chain issues. We are no longer able to obtain the intranasal delivery device. We do not have adequate funding available to continue with an alternative intranasal delivery device.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- HealthPartners InstituteUniversity, hospital or other
- Study start
- 16 Aug 2023 (actual)
- Primary completion
- 28 Jun 2024 (actual)
- Study completion
- 28 Jun 2024 (actual)
- First posted
- 19 May 2023 (actual)
- Results
- Posted 18 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to find out whether insulin, a drug approved by the FDA for the treatment of diabetes mellitus, reaches the brain and spinal cord when delivered as a nasal spray (intranasally). Intranasal insulin has been shown to improve memory and mood in patients with mild cognitive impairment and dementia, but more evidence is needed to support the ability to effectively target the brain through intranasal routes.
12 healthy adults will be randomly assigned to receive a single dose of either 40 units ("low dose" group) or 80 units ("high dose" group) of insulin. Participants will undergo image-guided lumbar puncture (spinal tap) performed by a study radiologist. Samples of cerebrospinal fluid (a fluid surrounding the brain and spinal cord) and blood will be collected at 5 timepoints during the lumbar puncture: once prior to the administration of intranasal insulin, and again at 10, 20, 30, and 40 minutes after the dose is given. Samples will be tested to determine the level of insulin detected in the cerebrospinal fluid and blood at each time point. Results of this study will provide essential information about the ability of the SipNose device to effectively deliver insulin to the central nervous system of humans as measured in the cerebrospinal fluid.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low dose Intranasal Insulin | Experimental | Drug: Low dose Regular InsulinOne dose of 40 international units of regular insulin administered intranasally using the SipNose SP1N1C1 device. |
| High dose Intranasal Insulin | Experimental | Drug: High dose Regular insulinOne dose of 80 international units of regular insulin administered intranasally using the SipNose SP1N1C1 device. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Subject is between ≥18 and ≤ 35 years of age
- Subject's body mass index is between >=18.5 and <=24.9
- Subject must be proficient in speaking English to comply with instructions and measures for the study
- Subject can provide written informed consent
- 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.
Key exclusion criteria (7 listed)
- 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.
- 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
- Subject has participated in a clinical trial investigation within 3 months of this study.
- Subject has an insulin allergy
- Subject has Insulin-dependent diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low dose Regular InsulinAlso: Novolin-RRegular insulin administered intranasally at either 40 IU | Drug | Low dose Intranasal Insulin |
| High dose Regular insulinAlso: Novolin-RRegular insulin administered intranasally at either 80 IU | Drug | High dose Intranasal Insulin |
Primary outcome
Insulin Concentration Over Time - Cerebrospinal Fluid
Time frame: 0-40 minutes post-intranasal administration
Insulin concentration detected in cerebrospinal fluid at 5 time points (pre-insulin dose; and 10, 20, 30 ,40 minutes after dose). Values will be reported as μIU/mL. Higher values indicate a greater concentration of insulin in the cerebrospinal fluid. Concentrations for each time point (overall and by dose) will be reported as a mean +/- standard deviation. The limit of detection of the assay was 0.15mU/L (0.0065µg/L).
Cmax of Insulin Concentration - Cerebrospinal Fluid
Time frame: 0-40 minutes post-intranasal administration
CSF insulin concentration will also be reported by Cmax (peak concentration)
Tmax of Insulin Concentration - Cerebrospinal Fluid
Time frame: 0-40 minutes post-intranasal administration
CSF insulin concentration will also be reported by Tmax (time of peak concentration)
AUC (Area Under the Curve) of Insulin Concentration - Cerebrospinal Fluid
Time frame: 0-40 minutes post-intranasal administration
CSF insulin concentration will also be reported by AUC (area under the curve, measured as time x concentration).
4 secondary outcomes
Insulin Concentration Over Time - Serum
Time frame: 0-40 minutes post-intranasal administration
Cmax of Insulin Concentration - Serum
Time frame: 0-40 minutes post-intranasal administration
Tmax of Insulin Concentration - Serum
Time frame: 0-40 minutes post-intranasal administration
AUC (Area Under the Curve) of Insulin Concentration - Serum
Time frame: 0-40 minutes post-intranasal administration
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leah R Hanson, PhD principal investigator
HealthPartners Neuroscience Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Low dose Regular Insulin and High dose Regular insulin in people with Healthy, run by HealthPartners Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin Concentration Over Time - Cerebrospinal Fluid (time frame: 0-40 minutes post-intranasal administration). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.