Transdermal Insulin Response In Healthy Volunteers

NCT04857320 | Completed Early Phase 1 Results FDA Drug

• 1 other identifier: LEV 101-D-022521
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Pharmacodynamic Response to Small Doses of Insulin

Outcome Measures

Primary Outcomes (2)

• Postprandial Serum Glucose in mg/dL as a Response to Small Doses (0.075 to 0.15 IUs/Kg) Human Insulin Averaged Per Subject

  An Average Postprandial serum glucose measured by the Continuous Glucose Monitor as a response to a single dose of Human Insulin averaged (Mean) for each Subject. Data is reported in mg/dL. The Average reported was a comparison from Baseline (Day 1) and up to 3.5 hours following each dose (assessed at Day 1 - Baseline, Day 2 - Dose 1, Day 3 - Dose 2, and Day 4 - Dose 3)"

  Pre-dose Baseline & a Mean of readings over 3.5 hours

• Daily Average Serum Glucose Measured in mg/dL as a Response to Small Doses (0.075 to 0.15 IUs/Kg) Human Insulin

  Daily average serum glucose measured by the Continuous Glucose Monitor in measured in mg/dL as a response to a single dose of Human Insulin and reported by the Freestyle 14-day software. Data was collected 4 times an hour throughout the test period and across doses. The prandial segments were included in this average. Data is reported in mg/dL by subject.

  72 hours

Secondary Outcomes (1)

• OECD Acute Dermal Irritation/Corrosion Score According to to the Organisation for Economic Co-operation and Development (OECD) Guideline for Testing of Chemicals No. 404

  20 Days

Study Arms (1)

Main Experimental

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

Combination Product: Human insulin

Interventions

Human insulin COMBINATION_PRODUCT

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

Main Experimental

Eligibility Criteria

• Age: 20 Years - 60 Years
• Gender Eligibility Details: Male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• The subject has a serum protein HbA1c of less than 6.
• The subject is willing and able to read, understand the Subject Information Sheet and provide written informed consent.
• The subject has a body mass index (BMI) within 18-50 kg/m2.
• The subject is in otherwise good health as determined by medical history and physical examination.
• The subject is a non-smoker.
• The subject must agree to continue with daily serum glucose testing by means of a wearable blood glucose for the pharmacokinetic assessments.
• The subject is willing and able to comply with all testing and requirements defined in the protocol.
• The subject is willing and able to return to the study site for all visits.

You may not qualify if:

• 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.
• The subject has had a clinically significant illness within 30 days preceding entry into this study.
• The subject has a history of significant neurological, hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, or metabolic disease.
• The subject has a known allergy or history of hypersensitivity to Human Insulin or similar modified Insulin compounds.
• The subject has used any prescription medication that may interfere with the evaluation of study medication.
• 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.
• The subject has a history of substance abuse or a current positive urine drug screen or urine alcohol test.
• Alcohol consumption greater than community norms (i.e. more than 21 standard drinks per week for males).
• Subjects who have received an investigational drug or have used an investigational device in the 30 days prior to study entry

Sponsors & Collaborators

• Transdermal Delivery Solutions Corp: lead
• Langford Research Institute, Inc.: collaborator

Study Sites (1)

Langford Research Institute

Palm Beach Gardens, Florida, 33410, 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: Managing Director
• Organization: LANGFORD RESEARCH INSTITUTE

KKirby@Langfordresearch.org

5614296429

Study Officials

• William D. Kirsh, D.O., M.P.H.

  Langford Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Healthy Males, aged 20 to 60, Non-diabetic and Hemoglobin A1c test results of less than 6.

Study Record Dates

• First Submitted: April 21, 2021
• First Posted: April 23, 2021
• Study Start: March 12, 2021
• Primary Completion: November 15, 2021
• Study Completion: November 15, 2021
• Last Updated: October 23, 2023
• Results First Posted: October 10, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)