A Physician-Initiated Multiple-Dose, Single Period, Phase 0-I Dose Ranging Study to Examine Transdermal Human Insulin Response In Healthy Volunteer Patients

• ClinicalTrials.gov Identifier: NCT04857320
• Recruitment Status: Active, not recruiting
• First Posted: April 23, 2021
• Last Update Posted: October 8, 2021
• Sponsor: Transdermal Delivery Solutions Corp
• Information provided by (Responsible Party): Transdermal Delivery Solutions Corp

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Pharmacodynamic Response to Small Doses of Insulin	Combination Product: Human insulin	Early Phase 1

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 experiemental data for each subject.

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 5 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Healthy Males, aged 20 to 60, Non-diabetic and Hemeglobin A1C of less than 6.
• Masking: None (Open Label)
• Primary Purpose: Device Feasibility
• Official Title: A Physician-Initiated Randomised, Multiple-Dose, Single Period, Phase II Dose Ranging Study to Examine HYpoSpray(R) Transdermal Human Insulin In Adult Healthy Volunteer Patients
• Actual Study Start Date: March 12, 2021
• Estimated Primary Completion Date: November 15, 2021
• Estimated Study Completion Date: January 15, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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	Combination Product: Human insulin; Human Insulin from recombinant source delivered in a solution capable of enabling transdermal delivery formulated at 100 IU/mL of delivery vehicle.

Outcome Measures

Primary Outcome Measures :

1. Pharmacodynamic response to Human Insulin [ Time Frame: 8 hours ]
   A slight dampening of postprandial serum glucose as measured by the Continuous Glucose Monitor. Data will be reoirted in mg/dL.
2. Pharmacodynamic response to Human Insulin [ Time Frame: 96 hours ]
   A slight dampening of baseline serum glucose levels as measured by the Continuous Glucose Monitor. Data will be reported in mg/dL.

Secondary Outcome Measures :

1. Skin Irritation [ Time Frame: 96 hours ]
   The skin at the application site will be assessed at each Clinic Visit by the investigator. Any dermal irritation will be scored according to to the OECD Guideline for Testing of Chemicals No. 404, adopted 17th July, 1992: "Acute Dermal Irritation/Corrosion":

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 60 Years (Adult)
• Sexes Eligible for Study: Male
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Male
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

1. The subject has a serum protein A1C 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

Contacts and Locations

Locations

United States, Florida

Langford Research Institute

Palm Beach Gardens, Florida, United States, 33410

Sponsors and Collaborators

Transdermal Delivery Solutions Corp

Investigators

• Principal Investigator: William D. Kirsh, D.O., M.P.H.; Langford Research Institute

More Information

• Responsible Party: Transdermal Delivery Solutions Corp
• ClinicalTrials.gov Identifier: NCT04857320
• Other Study ID Numbers: LEV 101-D-022521
• First Posted: April 23, 2021
• Last Update Posted: October 8, 2021
• Last Verified: September 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Insulin; Insulin, Globin Zinc; Hypoglycemic Agents; Physiological Effects of Drugs