ACTRN12616001072404WithdrawnNot Applicable
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 enrollmentStarted: August 10, 2016Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Enrollment
- 12
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Non-randomised trial
- Primary Purpose
- Treatment
Eligibility Criteria
- Ages
- 18 Years to o limit (—)
- Sex
- All
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Investigators
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