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Eptinezumab in Healthy Japanese Subjects

NCT ID: NCT04336449

Last Updated: 2020-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-01

Study Completion Date

2020-08-13

Brief Summary

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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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Detailed Description

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

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Cohort 1 100 mg eptinezumab

Group Type EXPERIMENTAL

Eptinezumab

Intervention Type DRUG

Eptinezumab - single intravenous infusion

Cohort 2 300 mg eptinezumab

Group Type EXPERIMENTAL

Eptinezumab

Intervention Type DRUG

Eptinezumab - single intravenous infusion

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo - single intravenous infusion

Interventions

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Eptinezumab

Eptinezumab - single intravenous infusion

Intervention Type DRUG

Placebo

Placebo - single intravenous infusion

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy Japanese subjects with a BMI of ≥ 18.5 and ≤ 25 kg/m2
Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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H. Lundbeck A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Email contact via H. Lundbeck A/S

Role: STUDY_DIRECTOR

[email protected]

Locations

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P-One Clinic

Tokyo, , Japan

Site Status

Countries

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Japan

Other Identifiers

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18899A

Identifier Type: -

Identifier Source: org_study_id

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