Subcutaneous Elafin in Healthy Subjects

What Was Tested

The trial (phase 1) is built around Elafin.

The purpose of this study is to assess Elafin that is being developed for treatment of PAH.

It had six arms (groups): one (experimental), one (experimental), one (experimental), one (experimental) and one (experimental).

The registry classes the interventions as drug.

More on the Plan

There will be a total of up to 30 subjects randomly assigned to 5 groups with 6 subjects in each group.

One subject in each group will be assigned to placebo drug and 5 subjects to active drug.

Each subject will be followed over a 28 day time period.

The study is also designed to absorb a de-escalation strategy.

Who Took Part

The registry lists 30 actual participants took part.

It was open to people of any sex aged from 18 years up to 55 years.

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

Examples of who could join: Male or female, 18 - 55 years of age. No history or clinically relevant cardiovascular, renal, gastrointestinal, hepatic, metabolic, endocrine, neurological, or psychiatric abnormalities and is in general good health at screening examination. Normal or clinically acceptable ECG. Body mass index of 18.0 - 32.0 (kg/m2). Ability to communicate well with the investigator and to comply with the requirements of the entire study.

The full record lists 17 inclusion and 21 exclusion criteria; among the exclusions: administration of any investigational drug 45 days prior to study enrollment; active participation in another interventional clinical trial; subject performed heavy physical exertion 2 days before eligibility assessment and before admission into clinical research center.

How the Study Was Run

Design: randomized, sequential and double-blind.

The participants were allocated by chance, so the Elafin group and the comparison group should start out alike.

Blinding on both sides kept the participants and researchers unaware of who received Elafin.

Those kept unaware of assignments: participant and care provider.

It started in 2019-03-18 with completion listed for 2019-10-25.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Incidence of Treatment-Emergent Adverse Events in healthy controls (time frame: 28 day time period).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Elafin in 30 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 Elafin compound page, all human trials.