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

Robert Silbergleit

Status and phase

Completed

Phase 1

Conditions

Healthy

Out-Of-Hospital Cardiac Arrest

Treatments

Drug: Intranasal insulin

Study type

Interventional

Funder types

Other

Identifiers

NCT05062785

HUM00171279

Details and patient eligibility

About

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.

Full 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.

Enrollment

24 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.