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

Completed · Phase 1 · Has a placebo group

Conditions studied: Migraine

In brief

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.

Key facts

Study ID

NCT05304910

Run by

H. Lundbeck A/S

People needed

52

Starts

2022-03-18

Expected to finish

2022-10-30

Last updated by the study team

2022-11-10

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• PAREXEL International — Glendale, California, United States

Full record on ClinicalTrials.gov

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