CompletedNCT04976309Updated Jan 19, 2022

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

A Phase 1 interventional study of Lu AG09222 and Placebo in Healthy, sponsored by H. Lundbeck A/S. Completed at 1 site in Denmark. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-01-19.

Sponsored by H. Lundbeck A/S · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 25
Allocation: Randomized
Ages: 18 Years to 45 Years
Sex: All

Study summary

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

Read the detailed description

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.

Conditions studied

Healthy

Browse trials for

Headache 1,226

In context

Headache

1,226 studies on the registry are indexed under Headache; 202 are open to participants now.

This study's enrollment of 25 is below the median of 60 across 918 interventional studies indexed under Headache.

Browse Headache studies →

Lead sponsor

H. Lundbeck A/S is the lead sponsor of 218 studies on the registry; 10 are open to participants now.

Of its 33 completed or terminated interventional studies of FDA-regulated products, 10 (30%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 45 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

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

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.

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 25 participants (actual)

Study arms

Experimental
Placebo + saline
Placebo, 0.9% normal saline, single dose intravenous infusion over 30 minutes
Drug: Placebo
Experimental
Placebo + VIP and PACAP
Placebo, 0.9% normal saline, single dose intravenous infusion over 30 minutes
Drug: Placebo
Experimental
Lu AG09222 + VIP and PACAP
Lu AG09222, single dose intravenous infusion over 30 minutes
Drug: Lu AG09222

Interventions

DrugLu AG09222
Single dose
DrugPlacebo
Single dose

What researchers measure

Primary outcomes

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
Time frame: 0 to 120 min after infusion

Secondary outcomes

Change from start of infusion in STA diameter to 60 min after start of infusion of PACAP38
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 0 to 120 min after infusion

Study locations

1 site

Danish Headache Center Rigshospitalet Glostrup
Glostrup, 2600, Denmark

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jan 19, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04976309
Lead sponsor: H. Lundbeck A/S
Responsible party: Sponsor
First posted: Jul 26, 2021
Start date: Jul 15, 2021
Primary completion: Sep 19, 2021
Completion: Dec 10, 2021
Last update: Jan 19, 2022

Study contacts

Email contact via H. Lundbeck A/S

study director · LundbeckClinicalTrials@lundbeck.com

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Headache→

Other studies from this sponsor

H. Lundbeck A/S

Start the discussion