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Safety, Tolerability and Pharmacokinetics of Eptinezumab in Healthy Chinese Subjects

Healthy Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05045781
Study type Interventional
Source H. Lundbeck A/S
Contact
Status Completed
Phase Phase 1
Start date April 20, 2021
Completion date July 20, 2021
View Details
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