Intra-Arterial Microdosing: Proof-of-Concept in Humans

What Was Tested

In this early phase 1 trial, researchers set out to test Insulin (regular human).

It had two arms (groups): Intra-Arterial Microdose Insulin (experimental) and Systemic Insulin (active comparator).

Healthy volunteers will receive microdose insulin intra-arterially into the radial artery.

The registry classes the interventions as drug.

More on the Plan

IAM is a novel approach combining the methodologies and techniques of 'microdosing' and 'intra-arterial drug delivery' to test new drugs in targeted organs or tissues.

The drug then returns systemically and is diluted to become a subpharmacological microdose.

Insulin will be administered into the radial artery and compared with systemic administration.

The effects on the ipsilateral hand will be compared with systemic effects and effects on the contralateral hand.

Who Took Part

10 actual participants took part.

It was open to men only aged from 18 years up to 40 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form. Subject's health status will be determined by the medical history, physical examination, vital signs, electrocardiogram, blood chemistry, hematology, and urinalysis performed at screening. Subjects must be willing to fast a minimum of 8 hours. Subjects must be willing to abstain from alcohol from 2 days prior to Day 1 of the study until discharge. Subjects must be willing to remain in the clinical research unit for the inpatient portion of the study from admission to discharge on Day 1.

The full record lists 9 inclusion and 29 exclusion criteria; among the exclusions: currently abusing drugs or alcohol or with a history of drug or alcohol abuse within the past two years; unwillingness or lack of ability to comply with the protocol or cooperate fully with the principal investigator and site personnel; use of any of the following:.

How the Study Was Run

The set-up was randomized, crossover and double-blind.

Because people in this Insulin (regular human) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Each person switched between Insulin (regular human) and the comparison at some point, usually with a gap in between.

Blinding on both sides kept the participants and researchers unaware of who received Insulin (regular human).

Those kept unaware of assignments: participant and outcomes assessor.

It started in 2014-12 with completion listed for 2015-07.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Glucose Plasma Levels (time frame: 2 hours). 18F-FDG Uptake as measured with Positron Emission Tomography (PET) imaging (time frame: 2 hours).

It also tracked 2 secondary outcomes, for example Potassium Plasma Levels and Lactic Acid Plasma Levels.

What This Means in Plain Language

Put simply, this is a early phase 1, randomized trial of Insulin (regular human) in 10 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin (regular human) compound page, all human trials.