Eptinezumab in Healthy Japanese Subjects

H. Lundbeck A/S18 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Healthy

Interventions

EptinezumabDRUG

Eptinezumab - single intravenous infusion

PlaceboDRUG

Placebo - single intravenous infusion

Eligibility

Sex: ALLMin age: 20 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy Japanese subjects with a BMI of ≥ 18.5 and ≤ 25 kg/m2 Other in- and exclusion criteria may apply

Locations (1)

P-One Clinic

Tokyo, Japan

Outcomes

Primary Outcomes

Cmax eptinezumab

maximal observed plasma concentration

Time frame: From dosing to week 12

AUC(0-t) eptinezumab

area under the plasma concentration-time curve from zero to time t

Time frame: From dosing to week 12

AUC(0-inf) eptinezumab

area under the plasma concentration-time curve from zero to infinity

Time frame: From dosing to week 12

Systemic Clearance of eptinezumab

Time frame: From dosing to week 12

Data from ClinicalTrials.gov

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