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

NCT ID: NCT05304910

Last Updated: 2022-11-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-18
• Study Completion Date: 2022-10-30

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.

Conditions

Migraine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Lu AG09222 Low Dose

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

Group Type: EXPERIMENTAL

Lu AG09222

Intervention Type: DRUG

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

Lu AG09222 High Dose

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

Group Type: EXPERIMENTAL

Lu AG09222

Intervention Type: DRUG

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

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

Lu AG09222

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

H. Lundbeck A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Email contact via H. Lundbeck A/S

Role: STUDY_DIRECTOR

H. Lundbeck A/S

Locations

PAREXEL International

Glendale, California, United States

Countries

United States

Other Identifiers

19825A

Identifier Type: -

Identifier Source: org_study_id