Transdermal Insulin Response In Healthy Volunteers

NCT ID: NCT04857320

Last Updated: 2023-10-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-12
• Study Completion Date: 2021-11-15

Brief Summary

Bio-fermentation produced Human insulin is available without prescription in the U.S. This study is a physician-initiated trial of a formula enabling transdermal delivery of human insulin.

Detailed Description

The primary objective of the study is to determine the amount of lowering serum glucose as a function of dose of a topically applied formulation of Human Insulin administered by syringe measurement to adult Healthy Volunteer subjects as compared to no treatment. A 5-day period of daily blood sugar monitoring by means of wearable Continuous Glucose Monitor and insulin dosing for 3 days then monitoring for at least 3 days following will form the baseline and experimental data for each subject.

The secondary objective is to evaluate the tolerability and local and systemic effects of transdermal Human Insulin if any.

Conditions

Pharmacodynamic Response to Small Doses of Insulin

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

Main Experimental

Each subject will receive doses applied to the skin of 0.075 IUs / Kilogram Body Weight, 0.1 IUs/Kilogram Body Weight and 0.15 IUs /Kilogram Body Weight

Group Type: EXPERIMENTAL

Human insulin

Intervention Type: COMBINATION_PRODUCT

Human Insulin from recombinant source delivered in a solution capable of enabling transdermal delivery formulated at 100 IU/mL of delivery vehicle.

Interventions

Human insulin

Human Insulin from recombinant source delivered in a solution capable of enabling transdermal delivery formulated at 100 IU/mL of delivery vehicle.

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

Inclusion Criteria

1. The subject has a serum protein HbA1c of less than 6.

2. The subject is willing and able to read, understand the Subject Information Sheet and provide written informed consent.

3. The subject has a body mass index (BMI) within 18-50 kg/m2.

4. The subject is in otherwise good health as determined by medical history and physical examination.

5. The subject is a non-smoker.

6. The subject must agree to continue with daily serum glucose testing by means of a wearable blood glucose for the pharmacokinetic assessments.

7. The subject is willing and able to comply with all testing and requirements defined in the protocol.

8. The subject is willing and able to return to the study site for all visits.

Exclusion Criteria

1. The subject has any relevant deviations from normal other than blood glucose in physical examination, electrocardiogram (ECG), or clinical laboratory tests, as evaluated by the investigator.

2. The subject has had a clinically significant illness within 30 days preceding entry into this study.

3. The subject has a history of significant neurological, hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, or metabolic disease.

4. The subject has a known allergy or history of hypersensitivity to Human Insulin or similar modified Insulin compounds.

5. The subject has used any prescription medication that may interfere with the evaluation of study medication.

6. The subject has donated or lost a significant volume of blood (>450 mL) within four (4) weeks of the study, and their Haemoglobin concentration and haematocrit have not returned to within 5% of normal.

7. The subject has a history of substance abuse or a current positive urine drug screen or urine alcohol test.

8. Alcohol consumption greater than community norms (i.e. more than 21 standard drinks per week for males).

9. Subjects who have received an investigational drug or have used an investigational device in the 30 days prior to study entry

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Langford Research Institute, Inc.

INDUSTRY

Sponsor Role: collaborator

Transdermal Delivery Solutions Corp

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

William D. Kirsh, D.O., M.P.H.

Role: PRINCIPAL_INVESTIGATOR

Langford Research Institute

Locations

Langford Research Institute

Palm Beach Gardens, Florida, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Informed Consent Form

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

LEV 101-D-022521

Identifier Type: -

Identifier Source: org_study_id