Clinical trial NCT04857320: Transdermal Insulin Response In Healthy Volunteers
Official title: A Physician-Initiated Randomised, Multiple-Dose, Single Period, Phase II Dose Ranging Study to Examine Transdermal Human Insulin In Adult Healthy Volunteer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Pharmacodynamic Response to Small Doses of Insulin
Lead sponsor: Transdermal Delivery Solutions Corp
Sponsor class: INDUSTRY
Collaborators: name: Langford Research Institute, Inc.
First posted: 2021-04-23
Enrollment: 7
Sex: MALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Healthy Males, aged 20 to 60, Non-diabetic and Hemoglobin A1c test results of less than 6.
Primary purpose: DEVICE_FEASIBILITY

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.

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

Primary outcomes:
measure: Postprandial Serum Glucose in mg/dL as a Response to Small Doses (0.075 to 0.15 IUs/Kg) Human Insulin Averaged Per Subject
timeFrame: Pre-dose Baseline & a Mean of readings over 3.5 hours
measure: Daily Average Serum Glucose Measured in mg/dL as a Response to Small Doses (0.075 to 0.15 IUs/Kg) Human Insulin
timeFrame: 72 hours
Secondary outcomes:
measure: 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
timeFrame: 20 Days
Other outcomes:
Locations:
city: Palm Beach Gardens
country: United States
facility: Langford Research Institute
state: Florida
Study officials:
affiliation: Langford Research Institute
name: William D. Kirsh, D.O., M.P.H.
role: PRINCIPAL_INVESTIGATOR
References: