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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05304910

Enrollment

Registered

2022-03-31

Start date

2022-03-18

Completion date

2022-10-30

Last updated

2022-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Migraine

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.

Interventions

DRUGLu AG09222

Lu AG09222 will be administered per schedule specified in the arm description.

DRUGPlacebo

Placebo matching to Lu AG09222 will be administered per schedule specified in the arm description.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026