Status:
COMPLETED
A Study Investigating the Movement of Lu AG09222 Into, Through, and Out of the Body of Healthy Caucasian, Chinese, and Japanese Participants
Lead Sponsor:
H. Lundbeck A/S
Conditions:
Migraine
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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 tolerabili...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 18 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 30 2022
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT05304910
Start Date
March 18 2022
End Date
October 30 2022
Last Update
November 10 2022
Active Locations (1)
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1
PAREXEL International
Glendale, California, United States, 91206