NCT05045781

Safety, Tolerability and Pharmacokinetics of Eptinezumab in Healthy Chinese Subjects

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: H. Lundbeck A/S · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Eptinezumab	single iv infusion

Timeline

• Start date: 2021-04-20
• Primary completion: 2021-07-20
• Completion: 2021-07-20
• First posted: 2021-09-16
• Last updated: 2021-09-16

Locations

1 site across 1 country: China