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Status:

COMPLETED

Transdermal Insulin Response In Healthy Volunteers

Lead Sponsor:

Transdermal Delivery Solutions Corp

Collaborating Sponsors:

Langford Research Institute, Inc.

Conditions:

Pharmacodynamic Response to Small Doses of Insulin

Eligibility:

MALE

20-60 years

Phase:

EARLY_PHASE1

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...

Eligibility Criteria

Inclusion

  • 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.

Exclusion

  • 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

Key Trial Info

Start Date :

March 12 2021

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

November 15 2021

Estimated Enrollment :

7 Patients enrolled

Trial Details

Trial ID

NCT04857320

Start Date

March 12 2021

End Date

November 15 2021

Last Update

October 23 2023

Active Locations (1)

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1

Langford Research Institute

Palm Beach Gardens, Florida, United States, 33410