A Phase 0 Open-labelled Clinical Trial To Investigate The Safety of a Micro-dose of a Nanocelle'Trademark' Insulin Formulation Administered Oro-buccally in Healthy Adult Volunteers.

Medlab Clinical0 sites12 target enrollmentAugust 10, 2016

Overview

No summary available.

Registry

who.int

Start Date

August 10, 2016

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Sponsor

Medlab Clinical

•1\) 6 Females and 6 Males
•2\) Participants \> 18 years of age of entry on study
•3\) Cognitive ability to understand informed consent process and to give informed consent to the experimental treatment
•4\) Participants agree to undergo venipuncture on multiple occasions
•5\) Participants agree to adhere to the study protocol
•6\) Have not been prescribed or have had administered insulin or any other glucose lowering compound
•7\) No history of any chronic diseases

•1\) Any clinically relevant abnormal findings which, in the opinion of the investigators / clinicians, may put the participant at risk of adverse events because of participation in the clinical trial including: physical examination, clinical chemistry, haematology, urinalysis, vital signs
•2\) Diagnosis of Type 2 diabetes mellitus (administered insulin)
•3\) Diagnosis of Type 1 diabetes mellitus
•4\) Alcohol abuse
•5\) Pregnant or nursing an infant
•6\) Any psychiatric disorders by history or examination that would prevent completion of the study or result in possible adverse events for the participant
•7\) The current use of any dietary and herbal supplements
•8\) The use of illicit drugs