Measurement of Insulin Levels in Cerebral Spinal Fluid (CSF) of Healthy Adults After a Single Intranasal Dose

NCT05866367 | Terminated Phase 1 Results FDA Drug

• 1 other identifier: A21-299
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief 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). 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

Outcome Measures

Primary Outcomes (4)

• 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).

  0-40 minutes post-intranasal administration

• Cmax of Insulin Concentration - Cerebrospinal Fluid

  CSF insulin concentration will also be reported by Cmax (peak concentration)

  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)

  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).

  0-40 minutes post-intranasal administration

Secondary Outcomes (4)

• Insulin Concentration Over Time - Serum

  0-40 minutes post-intranasal administration

• Cmax of Insulin Concentration - Serum

  0-40 minutes post-intranasal administration

• Tmax of Insulin Concentration - Serum

  0-40 minutes post-intranasal administration

• AUC (Area Under the Curve) of Insulin Concentration - Serum

  0-40 minutes post-intranasal administration

Study Arms (2)

Low dose Intranasal Insulin

EXPERIMENTAL

One dose of 40 international units of regular insulin administered intranasally using the SipNose SP1N1C1 device.

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.

Drug: High dose Regular insulin

Interventions

Low dose Regular Insulin DRUG

Regular insulin administered intranasally at either 40 IU

Also known as: Novolin-R

Low dose Intranasal Insulin

High dose Regular insulin DRUG

Regular insulin administered intranasally at either 80 IU

Also known as: Novolin-R

High dose Intranasal Insulin

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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 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

Sponsors & Collaborators

• HealthPartners Institute: lead

Study Sites (1)

HealthPartners Neuroscience Center

Saint Paul, Minnesota, 55130, United States

Location

MeSH Terms

Interventions

Insulin

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Clinical Research Coordinator
• Organization: HealthPartners Institute Neuroscience Research

ClinicalTrials@HealthPartners.com

651-495-6363

Study Officials

• Leah R Hanson, PhD

  HealthPartners Neuroscience Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2023
• First Posted: May 19, 2023
• Study Start: August 16, 2023
• Primary Completion: June 28, 2024
• Study Completion: June 28, 2024
• Last Updated: November 18, 2025
• Results First Posted: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)