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Transdermal Insulin Response In Healthy Volunteers

NCT04857320 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2023-10-23

Study results available
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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

Interventions

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.

Sponsors & Collaborators

  • Langford Research Institute, Inc.

    collaborator INDUSTRY

  • Transdermal Delivery Solutions Corp

    lead INDUSTRY

Principal Investigators

  • William D. Kirsh, D.O., M.P.H. · Langford Research Institute

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
60 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-12
Primary Completion
2021-11-15
Completion
2021-11-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04857320 on ClinicalTrials.gov