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

Lundbeck

Status and phase: Completed; Phase 1

Conditions: Migraine

Treatments: Drug: Lu AG09222; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05304910

19825A

Details and patient eligibility

About

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.

Enrollment: 52 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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52 participants in 3 patient groups, including a placebo group

Lu AG09222 Low Dose

Experimental group

Description:

Participants will receive a single dose of Lu AG09222 by subcutaneous (SC) injection on Day 1.

Treatment:

Drug: Lu AG09222

Lu AG09222 High Dose

Experimental group

Description:

Participants will receive a single dose of Lu AG09222 by SC injection on Day 1.

Treatment:

Drug: Lu AG09222

Placebo

Placebo Comparator group

Description:

Participants will receive a single dose of placebo matching LU AG0922 by SC injection on Day 1.

Treatment:

Drug: Placebo