Eptinezumab in Healthy Japanese Subjects

Healthy Clinical Trial

Official title:

Interventional, Randomized, Double-blind, Placebo-controlled, Single-ascending-dose Study Investigating the Safety, Tolerability, and Pharmacokinetic Properties of Eptinezumab in Healthy Japanese Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04336449
• Other study ID #: 18899A
• Status: Completed
• Phase: Phase 1
• Start date: April 1, 2020
• Est. completion date: August 13, 2020

Study information

• Verified date: August 2020
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate how eptinezumab enters, moves through and exits the body. Safety and tolerability will also be investigated.

Description:

The study will consist of 18 healthy Japanese subjects, divided into two single dose cohorts with 9 subjects in each cohort.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: August 13, 2020
• Est. primary completion date: August 13, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 55 Years

Eligibility

Inclusion Criteria:

• Healthy Japanese subjects with a BMI of = 18.5 and = 25 kg/m2

Other in- and exclusion criteria may apply

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Eptinezumab
Eptinezumab - single intravenous infusion
• Placebo
Placebo - single intravenous infusion

Locations

Country	Name	City	State
Japan	P-One Clinic	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax eptinezumab	maximal observed plasma concentration	From dosing to week 12
Primary	AUC(0-t) eptinezumab	area under the plasma concentration-time curve from zero to time t	From dosing to week 12
Primary	AUC(0-inf) eptinezumab	area under the plasma concentration-time curve from zero to infinity	From dosing to week 12
Primary	Systemic Clearance of eptinezumab		From dosing to week 12