Safety, Tolerability and Pharmacokinetics of Eptinezumab in Healthy Chinese Subjects

Study Overview
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Brief Summary
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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
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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.

Official Title
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Interventional, Single-ascending-dose Study Investigating the Safety, Tolerability, and Pharmacokinetic Properties of Eptinezumab in Healthy Chinese Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: Eptinezumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Eptinezumab 100 mg<br> | Drug: Eptinezumab<br>* single iv infusion<br>|
| Experimental: Eptinezumab 300 mg<br> | Drug: Eptinezumab<br>* single iv infusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC(0-inf) eptinezumab | Area under the plasma concentration-time curve | Day 1 to Day 84 | 
| Maximal observed plasma concentration (Cmax) of eptinezumab |  | Day 1 to Day 84 | 
| Systemic clearance (CL) of eptinezumab | Eptinezumab dose/AUC(0-inf) | Day 1 to Day 84 | 
| tmax | Nominal time for the occurrence of Cmax (tmax) | Day 1 to Day 84 | 
| Apparent terminal elimination half-life (t½) |  | Day 1 to Day 84 |