A Study Investigating the Movement of Lu AG09222 Into, Through, and Out of the Body of Healthy Caucasian, Chinese, and Japanese Participants

Study Overview
=================
Brief Summary
-----------------
The main goal of the study is to learn more about how the body absorbs and eliminates Lu AG09222 after a single dose is injected under the skin. Researchers will also investigate safety and tolerability effects of Lu AG09222 after administration.

Official Title
-----------------
Interventional, Randomized, Double-blind, Parallel-group, Placebo-controlled, Single-dose Study Investigating the Safety, Tolerability and Pharmacokinetic Properties of Lu AG09222 in Healthy Caucasian, Chinese and Japanese Subjects

Conditions
-----------------
Migraine

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The participant is Japanese, defined as having 4 Japanese grandparents, or the participant is Caucasian, or the participant is Chinese, defined as having 4 Chinese grandparents. The participant has a body mass index (BMI) ≥18 and ≤28 kilograms (kg)/square meter (m^2) at the Screening Visit and at the Baseline Visit. Exclusion Criteria: The participant has or has had any clinically significant immunological, cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, or psychiatric disease or other major disorder. The participant has a history of cancer, other than basal cell or Stage 1 squamous cell carcinoma of the skin or adequately treated cervical intraepithelial neoplasia, that has not been in remission for >5 years prior to the first dose of investigational medicinal product (IMP). The participant has had major surgery (excluding laparoscopic cholecystectomy or uncomplicated appendectomy) <6 months prior to the first dose of IMP. The participant has previously been dosed with Lu AG09222. The participant has a history of severe drug allergy or hypersensitivity. Other inclusion and exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lu AG09222 Low Dose<br>Participants will receive a single dose of Lu AG09222 by subcutaneous (SC) injection on Day 1. | Drug: Lu AG09222<br>* Lu AG09222 will be administered per schedule specified in the arm description.<br>|
| Experimental: Lu AG09222 High Dose<br>Participants will receive a single dose of Lu AG09222 by SC injection on Day 1. | Drug: Lu AG09222<br>* Lu AG09222 will be administered per schedule specified in the arm description.<br>|
| Placebo Comparator: Placebo<br>Participants will receive a single dose of placebo matching LU AG0922 by SC injection on Day 1. | Drug: Placebo<br>* Placebo matching to Lu AG09222 will be administered per schedule specified in the arm description.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Lu AG09222 Serum Concentration-Time Curve (AUC) From Zero to Infinity (AUC0-inf) |  | Day 1 (predose) to Day 84 | 
| Maximum Observed Concentration (Cmax) of Lu AG09222 |  | Day 1 (predose) to Day 84 | 
| Apparent Elimination Half-Life (t½) of Lu AG09222 |  | Day 1 (predose) to Day 84 | 
| Time to Maximum Observed Concentration (tmax) |  | Day 1 (predose) to Day 84 | 
| Apparent Total Clearance (CL/F) |  | Day 1 (predose) to Day 84 | 
| Apparent Volume of Distribution (Vz/F) |  | Day 1 (predose) to Day 84 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Specific Anti-Lu AG09222 Antibodies (Anti-Drug Antibodies [ADA]) |  | Day 1 (predose) to Day 84 | 
| Number of Participants With Specific ADA-Positive Samples for Neutralizing Antibodies (NAb) |  | Day 1 (predose) to Day 84 |