Study to Assess the Pharmacodynamic Effects of Unfractionated Heparin (UFH) in Healthy Volunteers With and Without Bendavia

What Was Tested

This registered phase 1 trial tested SS-31 (Elamipretide).

It had two arms (groups): UFH + Placebo (placebo comparator) and UFH + Bendavia (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 12 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: Healthy adult males or females aged between 18 and 65 years of age with signed informed consent.

The full record lists 2 inclusion and 26 exclusion criteria; among the exclusions: serum sodium level below the lower limit of the site's clinical laboratory normal range at both study period qualification visits,; platelet value below the lower limit of normal range at screening or admission,; aptt value outside the normal range at screening or admission,.

How the Study Was Run

Design: randomized, crossover and quadruple-blind.

Because people in this SS-31 (Elamipretide) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

In the crossover set-up each of the participants took both SS-31 (Elamipretide) and the comparison in turn, acting as their own control.

Blinding on both sides kept the participants and researchers unaware of who received SS-31 (Elamipretide).

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2012-01 with completion listed for 2012-02.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): Mean difference over 24 hours in aPTT (activated partial prothrombin time) in seconds when UFH is administered with and without Bendavia (time frame: Pre-UFH to 24 hours post-study drug administration).

It also tracked 3 secondary outcomes, for example Mean difference over 12 hours of anti-factor Xa (IU/mL) when UFH is administered with and without Bendavia and Difference in number of adverse events when UFH is administered with and without Bendavia.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of SS-31 (Elamipretide) in 12 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 SS-31 (Elamipretide) compound page, all human trials.