The Impact of Intravenous Bendavia™ on Endothelial Reactivity Dysfunction in Cigarette Smoking

What Was Tested

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

This will be a phase 1 randomized, double-blind, 2-period, 2-sequence crossover trial enrolling 6 healthy volunteers to assess the impact of IV-administered Bendavia on the endothelial dysfunction induced by a single cigarette.

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

The registry classes the interventions as drug and other.

Who Took Part

The registry lists 6 actual participants took part.

It was open to men only aged from 18 years up to 65 years.

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

The full record lists 0 inclusion and 18 exclusion criteria; among the exclusions: serum sodium level below the lower limit of sites' clinical laboratory normal range at screening, d-1 and 6; hypertension (blood pressure sbp \> 140, dbp \> 90 mmhg); body mass index \< 18 or \> 32 kg/m2,.

How the Study Was Run

Design: randomized, crossover and quadruple-blind.

The participants were allocated by chance, so the SS-31 (Elamipretide) group and the comparison group should start out alike.

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

As a double-blind SS-31 (Elamipretide) study, the assignments were hidden from both participants and investigators until the end.

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

It started in 2012-01 with completion listed for 2012-03.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): Analysis of variance (ANOVA) between group mean endothelial function (EndoPAT Index) following smoking a single cigarette with and without Bendavia (time frame: Baseline, +30, +60, +90 minutes post-study-drug administration start).

It also tracked 5 secondary outcomes, for example Anova between group mean inflammatory laboratory marker (hs-CRP; mg/L) after smoking one cigarette with and without Bendavia, ANOVA between group means of urinary 8-isoprostane (ng/mg of creatinine) after smoking one cigarette with and without Bendavia, Number adverse events with and without Bendavia, Assessment of Bendavia exposure measured by area Under the Curve (AUC; ng*hr/mL) and ANOVA between group means of urinary 8-hydroxy-2'-deoxyguanosine (pg/mL) after smoking one cigarette with and without Bendavia.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of SS-31 (Elamipretide) in 6 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.