A Single Dose Study of Lu AG09222 in a Headache Model With Healthy Subjects

Study Overview
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Brief Summary
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The purpose of this study is to evaluate how well Lu AG09222 can prevent blood vessel dilation in a headache model.

Detailed Description
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This study will investigate the effect of preventive treatment with Lu AG09222 on vasodilation, heart rate increase, and headache induced by PACAP and VIP. Subjects will be randomised to three arms, placebo + saline, placebo + VIP and PACAP, and Lu AG09222 + VIP and PACAP. Subjects who complete the study will attend a safety follow-up visit at 10 to 12 weeks after administration of investigational medicinal product.

Official Title
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Interventional, Randomized, Double-blind, Parallel-group, Placebo-controlled Study Investigating the Effect of Lu AG09222 on PACAP38- and VIP-induced Vasodilation, Heart Rate Increase, and Headache in Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: Lu AG09222
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The subject has a body mass index (BMI) ≥ 18.0 and ≤ 30.0 kg/m2, and a body weight ≥ 45 and ≤ 95 kg at the screening visit. The subject is, in the opinion of the investigator, generally healthy based on medical history, a physical examination, vital signs, an ECG, and the results of the clinical chemistry, haematology, urinalysis, serology, and other laboratory tests at screening. Exclusion Criteria: The subject fulfils the diagnostic criteria for a primary headache disorder, or has a first degree relative with a primary headache disorder, according to the International Headache Society (IHS) International Classification of Headache Disorders 3rd edition (ICHD-3), except tension-type headache. The subject has or has had tension-type headache more than once per month on average during the 6 months prior to the screening visit. Other inclusion and exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Placebo + saline<br>Placebo, 0.9% normal saline, single dose intravenous infusion over 30 minutes | Drug: Placebo<br>* Single dose<br>|
| Experimental: Placebo + VIP and PACAP<br>Placebo, 0.9% normal saline, single dose intravenous infusion over 30 minutes | Drug: Placebo<br>* Single dose<br>|
| Experimental: Lu AG09222 + VIP and PACAP<br>Lu AG09222, single dose intravenous infusion over 30 minutes | Drug: Lu AG09222<br>* Single dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the curve (AUC) of change from start of infusion in superficial temporal artery (STA) diameter from 0 to 120 min after start of infusion of PACAP38 |  | 0 to 120 min after infusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from start of infusion in STA diameter to 60 min after start of infusion of PACAP38 |  | 0 to 60 min after infusion | 
| Maximum change from start of infusion in STA diameter between 0 and 120 min after start of infusion of PACAP38 |  | 0 and 120 min after infusion | 
| AUC in change from start of infusion in facial blood flow from 0 to 120 min after start of infusion of PACAP38 |  | 0 to 120 min after infusion | 
| AUC in change from start of infusion in heart rate from 0 to 120 min after start of infusion of PACAP38 |  | 0 to 120 min after infusion |