Healthy
Conditions
Brief 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.
Detailed description
This is an interventional, randomized, open-label, parallel-group, single-dose study investigating the safety, tolerability and pharmacokinetic properties of eptinezumab administered by intravenous (iv) infusion. The study will consist of 20 healthy Chinese subjects, who will be randomized into two single-dose groups. The two groups will be run in parallel. In Group 1, a total of 10 subjects will receive a single iv infusion of 100 mg eptinezumab on Day 1. In Group 2, a total of 10 subjects will receive a single iv infusion of 300 mg eptinezumab on Day 1. Safety and tolerability will be assessed throughout the study. Blood samples for plasma quantification of free eptinezumab will be collected from Day 1 to the Completion Visit (Day 84)/Withdrawal Visit.
Interventions
DRUGEptinezumab
single iv infusion
Sponsors
H. Lundbeck A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUC(0-inf) eptinezumab | Day 1 to Day 84 | Area under the plasma concentration-time curve |
| Maximal observed plasma concentration (Cmax) of eptinezumab | Day 1 to Day 84 | — |
| Systemic clearance (CL) of eptinezumab | Day 1 to Day 84 | Eptinezumab dose/AUC(0-inf) |
| tmax | Day 1 to Day 84 | Nominal time for the occurrence of Cmax (tmax) |
| Apparent terminal elimination half-life (t½) | Day 1 to Day 84 | — |
Countries
China
Outcome results
None listed