Overview
Safety, Tolerability and Pharmacokinetics of Eptinezumab in Healthy Chinese Subjects
Status:
Completed
Completed
Trial end date:
2021-07-20
2021-07-20
Target enrollment:
0
0
Participant gender:
All
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 1Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
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