Safety, Tolerability and Pharmacokinetics of Single Dose Polyethylene Glycolated Exenatide Injection (PB-119) in Healthy Volunteers

What Was Tested

This randomized controlled trial paper looks at Exenatide.

Exenatide promotes insulin secretion and inhibits postprandial glucagon secretion.

Polyethylene glycolated exenatide injection (PB-119), a derivative obtained by modification of exenatide, is more stable in metabolic behavior than exenatide in vivo.

Why It Was Studied

The study was registered at clinicaltrials.gov (No.

Who Took Part

The abstract describes 8 subjects taking part.

PubMed indexes the participants as adults, both men and women.

The 2- to 50-µg groups had 8 subjects in each group (the ratio of test preparation to placebo was 3:1), and the 100- to 400-µg groups had 10 subjects in each group (the ratio of test preparation to placebo was 4:1).

After medication, the vital signs of the subjects were monitored, and laboratory tests and electrocardiogram tests were carried out regularly in all the subjects.

How the Study Was Run

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

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

Blinding on both sides kept the subjects and researchers unaware of who received Exenatide.

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

The tolerability test was conducted in the 2- to 10-µg groups.

What Was Measured

PubMed files the paper under topics including Exenatide, Half-Life, Hypoglycemic Agents and Polyethylene Glycols.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Exenatide in 8 subjects.

With fewer than 40 people, it is a small study, so it is better read as an early signal for further research than as a settled answer.

The abstract goes on to report its results in about 6 sentences; this page does not restate them, so read the paper for the findings and their limits.

The publication is from 2020 (European journal of drug metabolism and pharmacokinetics), a journal based in France.

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