Eptinezumab in Healthy Japanese Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Eptinezumab; Drug: Placebo

• Registration Number: NCT04336449
• Lead Sponsor: H. Lundbeck A/S

Brief 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.

Detailed Description

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

Study Timeline

• Study Start: 2020-04-01
• Study First Submitted: 2020-04-03
• Study First Submitted QC: 2020-04-03
• Study First Posted: 2020-04-07
• Status Verified: 2020-08
• Primary Completion: 2020-08-13
• Study Completion: 2020-08-13
• Last Update Submitted: 2020-08-13
• Last Update Posted: 2020-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

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

Other in- and exclusion criteria may apply

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Cohort 2 300 mg eptinezumab	Eptinezumab	-
Placebo	Placebo	-
Cohort 1 100 mg eptinezumab	Eptinezumab	-

Primary Outcome Measures

Name	Time	Method
AUC(0-inf) eptinezumab	From dosing to week 12	area under the plasma concentration-time curve from zero to infinity
Systemic Clearance of eptinezumab	From dosing to week 12
Cmax eptinezumab	From dosing to week 12	maximal observed plasma concentration
AUC(0-t) eptinezumab	From dosing to week 12	area under the plasma concentration-time curve from zero to time t

Trial Locations

Locations (1)

P-One Clinic; 🇯🇵 Tokyo, Japan