Study design and participants
headache
This was a phase 1, interventional, randomized, double-blind, parallel-group, placebo-controlled, single-dose study investigating the effect of Lu AG09222 in a headache model with healthy volunteers. This study was designed in accordance with the Declaration of Helsinki and conducted in compliance with Good Clinical Practice and applicable regulatory requirements; all participants provided informed consent prior to participation. There were four notable protocol deviations, none of which affected the integrity of the study or subject safety; see Additional file Healthy adults aged 18–45 years (inclusive) with a body mass index ≥ 18.0 and ≤ 30.0 kg/m