Safety, tolerability and pharmacokinetics/pharmacodynamics of the adrenomedullin antibody adrecizumab in a first-in-human study and during experimental human endotoxaemia in healthy subjects

What Was Tested

The paper reports a study of Adrenomedullin, published as a randomized controlled trial.

Adrenomedullin (ADM) is an important regulator of endothelial barrier function and vascular tone, and may represent a novel treatment target in sepsis.

Who Took Part

PubMed indexes the participants as young adults and adults, men only.

Forty-eight healthy male volunteers were enrolled in two randomized, double-blind, placebo-controlled phase I studies.

How the Study Was Run

In design terms this was a randomized, double-blind and placebo-controlled study.

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

As a double-blind Adrenomedullin study, the assignments were hidden from both participants and investigators until the end.

The comparison arm used a placebo, so changes seen with Adrenomedullin could be set against what happens without it.

In the second study, a bolus of 1 ng kg-1 endotoxin was followed by infusion of 1 ng kg-1 h-1 endotoxin for 3 h to induce systemic inflammation, and the study medication infusion started 1 h after endotoxin bolus administration.

What Was Measured

PubMed files the paper under topics including Adrenomedullin, Antibodies, Monoclonal, Humanized, Endotoxemia, Escherichia coli, Half-Life, Healthy Volunteers and Human Experimentation.

The authors tagged it with the keywords adrecizumab, antibody, endotoxaemia, sepsis and shock.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Adrenomedullin.

The abstract goes on to report its results in about 5 sentences; this page does not restate them, so read the paper for the findings and their limits.

The publication is from 2018 (British journal of clinical pharmacology), a journal based in England.

More context: the Adrenomedullin compound page, all human trials.