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

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

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.

Study Overview

• Status: Completed
• Conditions: Migraine
• Intervention / Treatment: Drug: Lu AG09222; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Glendale, California, United States, 91206
      • Parexel International

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: H. Lundbeck A/S

Study record dates

Study Major Dates

• Study Start (Actual): March 18, 2022
• Primary Completion (Actual): October 30, 2022
• Study Completion (Actual): October 30, 2022

Study Registration Dates

• First Submitted: March 22, 2022
• First Submitted That Met QC Criteria: March 22, 2022
• First Posted (Actual): March 31, 2022

Study Record Updates

• Last Update Posted (Actual): November 10, 2022
• Last Update Submitted That Met QC Criteria: November 8, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 19825A

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No