Safety, Tolerability and Pharmacokinetics of Eptinezumab in Healthy Chinese Subjects

• Status: Completed
• Trial end date: 2021-07-20
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to investigate how the body absorbs and get rid of eptinezumab when given directly into a vein in Chinese subjects.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: H. Lundbeck A/S

Criteria

Inclusion Criteria:

• BMI of ≥ 19 and ≤ 25 kg/m2.

• The subject is Chinese, defined as being born in China and having four Chinese grandparents.

• The subject is, in the opinion of the investigator, generally healthy based on medical history, a physical examination, vital signs, an ECG, and the results of the clinical chemistry, haematology, urinalysis, serology, and other laboratory tests.

Exclusion Criteria:

• The subject is pregnant or breastfeeding.

• The subject 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.

Other inclusion and exclusion criteria may apply