Safety and tolerability of LBR-101, a humanized monoclonal antibody that blocks the binding of CGRP to its receptor: Results of the Phase 1 program

What Was Tested

The paper reports a study of CGRP (Calcitonin Gene-Related Peptide), published as a randomized controlled trial.

The objective of this article is to characterize the safety and tolerability of LBR-101 when administered intravenously to healthy volunteers, by presenting the pooled results of the Phase 1 program.

Why It Was Studied

LBR-101 is a fully humanized monoclonal antibody that binds to calcitonin gene-related peptide.

Who Took Part

According to the abstract, 94 subjects were involved.

The age groups tagged for this paper are teenagers, young adults, adults, middle-aged adults and older adults, both men and women.

LBR-101 was administered to 94 subjects, while 45 received placebo.

How the Study Was Run

The researchers set it up as a randomized, double-blind, placebo-controlled and crossover study.

Random assignment meant chance, not the researchers, decided who got CGRP (Calcitonin Gene-Related Peptide) and who got the comparison, which limits bias.

Blinding on both sides kept the subjects and researchers unaware of who received CGRP (Calcitonin Gene-Related Peptide).

A placebo (an inactive look-alike) gave the CGRP (Calcitonin Gene-Related Peptide) group a baseline to be compared against.

Each person switched between CGRP (Calcitonin Gene-Related Peptide) and the comparison at some point, usually with a gap in between.

What Was Measured

Topics PubMed links to this paper include Adverse Drug Reaction Reporting Systems, Antibodies, Monoclonal, Aortic Aneurysm, Thoracic, Calcitonin Gene-Related Peptide and Ehlers-Danlos Syndrome.

The authors tagged it with the keywords CGRP, LBR-101, Monoclonal antibodies and chronic migraine.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of CGRP (Calcitonin Gene-Related Peptide) in 94 subjects.

The abstract goes on to report its results in about 7 sentences; this page does not restate them, so read the paper for the findings and their limits.

The publication is from 2014 (Cephalalgia : an international journal of headache), a journal based in England.

More context: the CGRP (Calcitonin Gene-Related Peptide) compound page, all human trials.