Eptinezumab in Healthy Japanese Subjects

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04336449

Enrollment

Registered

2020-04-07

Start date

2020-04-01

Completion date

2020-08-13

Last updated

2020-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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.

Interventions

DRUGEptinezumab

Eptinezumab - single intravenous infusion

DRUGPlacebo

Placebo - single intravenous infusion

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

20 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy Japanese subjects with a BMI of ≥ 18.5 and ≤ 25 kg/m2 Other in- and

Exclusion criteria

may apply

Design outcomes

Primary

Measure	Time frame	Description
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
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	—

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026