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OpenTrials
Completed

NCT Number: NCT04336449

Eptinezumab in Healthy Japanese Subjects

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

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Key information

Conditions

Healthy

Age range

20 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

P-One Clinic

Tokyo, Japan

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Other in- and exclusion criteria may apply

Treatment and study plan

Eptinezumab

Drug

Eptinezumab - single intravenous infusion

Placebo

Drug

Placebo - single intravenous infusion

Primary outcomes

  1. Cmax eptinezumab

    Time frame: From dosing to week 12

    maximal observed plasma concentration

  2. AUC(0-t) eptinezumab

    Time frame: From dosing to week 12

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

  3. AUC(0-inf) eptinezumab

    Time frame: From dosing to week 12

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

  4. Systemic Clearance of eptinezumab

    Time frame: From dosing to week 12

Sponsors and collaborators

Lead sponsor

H. Lundbeck A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 7, 2020
Registry last updated
Aug 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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