CGRPR Antagonists and Acute Mountain Sickness

INTERVENTION: Trade Name: Aimovig Product Name: Erenumab Pharmaceutical Form: Solution for injection in pre‐filled syringe Pharmaceutical form of the placebo: Injection Route of administration of the placebo: Subcutaneous use CONDITION: Acute Mountain Sickness (AMS) is a constellation of symptoms (headache, anorexia, nausea, vomiting, lightheadedness, and fatigue) occuring in unacclimatized mountaineers ascending too fast, too high ; MedDRA version: 20.0 Level: LLT Classification code 10020045 Term: High altitude illness System Organ Class: 100000004863 Therapeutic area: Body processes [G] ‐ Physiological processes [G07] PRIMARY OUTCOME: Main Objective: Does Erenumab reduce the severity of AMS after a 12‐hours exposure to normobaric hypoxia at an oxygen concentration of 12% (corresponding to an altitude of 4500 m)? Primary end point(s): Severity of AMS measured by the means of the Lake Louise Score Secondary Objective: Does Erenumab reduce the incidence of AMS after a 12‐hours exposure to normobaric hypoxia at an oxygen concentration of 12% (corresponding to an altitude of 4500 m)? Timepoint(s) of evaluation of this end point: 12‐hours after beginning of exposure to normobaric hypoxia at an oxygen concentration of 12% SECONDARY OUTCOME: Secondary end point(s): Incidence of AMS Timepoint(s) of evaluation of this end point: 12‐hours after beginning of exposure to normobaric hypoxia at an oxygen concentration of 12% INCLUSION CRITERIA: ‐ Age 18‐60 years ‐ Good physical condition ‐ No relevant pathologies revealed upon the pre‐examination prior to the study ‐ Written informed consent to participate in the study ‐ Permanent residency below 1000 m ‐ Males and females are included without prioritization ‐ More than 3 weeks since vaccination against or full recovery from SARS‐CoV2 infection ‐ Negative serum or urine pregnancy test in women of childbearing potential if pregnancy cannot be ruled out Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range