Study to Evaluate Safety, Tolerability, and Pharmacokinetics (PK) of Intravenous (IV) Infusion of MTP-131 (Bendavia™) in Healthy Adults

What Was Tested

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

This is the first study of MTP-131 (Bendavia™) in humans.

It had five arms (groups): Arm 1 (experimental), Arm 2 (experimental), Arm 3 (experimental), Arm 4 (experimental) and Arm 5 (experimental).

The registry classes the interventions as drug.

More on the Plan

The primary objective of the study is to evaluate the safety and tolerability of MTP-131 in healthy volunteers following a single intravenous infusion.

This is a double-blind, placebo-controlled, randomized trial.

A total of 40 eligible subjects will be enrolled and randomized in a 3:1 active to placebo ratio for a total of 5 treatment groups of 8 volunteers.

As far as is logistically possible, each treatment group will have similar numbers of male and female volunteers.

Who Took Part

The registry lists 40 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Healthy adult males or females age ≥18 years of age with signed informed consent.

The full record lists 2 inclusion and 18 exclusion criteria; among the exclusions: BMI of less than 18 kg/m2 or greater than 32 kg/m2,; history of seizures or epilepsy,; history of serious mental illness,.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

Random assignment meant chance, not the researchers, decided who got SS-31 (Elamipretide) and who got the comparison, which limits bias.

The SS-31 (Elamipretide) group and the comparison group ran side by side rather than switching.

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 2010-05 with completion listed for 2010-09.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Treatment emergent adverse events in treatment group versus placebo group (time frame: 7 days).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of SS-31 (Elamipretide) in 40 people.

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.