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Insulin nasal drops pass early safety test in healthy volunteers

NCT ID NCT05062785

Knowledge-focused Sponsor: Robert Silbergleit Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage study tested whether giving regular insulin as nose drops is safe and tolerable in 24 healthy adults. Researchers aimed to find the highest dose that does not cause dangerously low blood sugar. The study was completed and focused on safety, not on treating any disease.

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

24 people

The number who actually took part.

Started

Oct 2021

Finished

Apr 2022

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 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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: * Good health based on medical history, physical exam, and routine laboratory testing. * Female participants must have negative urine pregnancy test or be surgically sterilized or postmenopausal. Criteria for menopause are surgical menopause (hysterectomy, oophorectomy) or age \> 45 years with the absence of menses for greater than 12 months. Tubal ligation with menses within the past 12 months is not considered to be surgical sterilization. * Body mass index (BMI) between 18 kilogram / square meter (kg/m2) and 35 kg/m2. * Willing and able to stay at the clinical research facility as required by the protocol * Willing and able to comply with the investigational nature of the study and able to communicate well with investigators * Ability to comprehend and willing to provide written informed consent in accordance with institutional and regulatory guidelines Exclusion Criteria: * Known allergy to insulin. * Preexisting diabetes. * Current or previous use of diabetes medication or insulin. * Any nasal disease or congestion that may interfere with intranasal drug absorption. * Baseline hypoglycemia (blood glucose ≤ 65 mg/dL) or hyperglycemia (blood glucose \> 200 mg/dL) as evident from the screening labs. * Active serious disease, such as liver disease, kidney disease, uncontrolled hypertension, clinically significant hypokalemia, and significant or unstable medical illness * Blood donation in excess of 500 milliliter (mL) within 60 days prior to the first dose of study medication. * Treated with an investigational drug within 30 days. * Individuals with inadequate venous access.

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Conditions

The condition(s) this trial relates to.

cardiac arrest Out-of-Hospital Cardiac Arrest

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Healthy Out-of-hospital cardiac arrest

Contacts and locations

Locations

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

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