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
1 other identifier
interventional
18
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 healthy
Started Apr 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2020
CompletedFirst Submitted
Initial submission to the registry
April 3, 2020
CompletedFirst Posted
Study publicly available on registry
April 7, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 13, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 13, 2020
CompletedAugust 14, 2020
August 1, 2020
4 months
April 3, 2020
August 13, 2020
Conditions
Outcome Measures
Primary Outcomes (4)
Cmax eptinezumab
maximal observed plasma concentration
From dosing to week 12
AUC(0-t) eptinezumab
area under the plasma concentration-time curve from zero to time t
From dosing to week 12
AUC(0-inf) eptinezumab
area under the plasma concentration-time curve from zero to infinity
From dosing to week 12
Systemic Clearance of eptinezumab
From dosing to week 12
Study Arms (3)
Cohort 1 100 mg eptinezumab
EXPERIMENTALCohort 2 300 mg eptinezumab
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eptinezumab - single intravenous infusion
Eligibility Criteria
You may qualify if:
- Healthy Japanese subjects with a BMI of ≥ 18.5 and ≤ 25 kg/m2
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- H. Lundbeck A/Slead
Study Sites (1)
P-One Clinic
Tokyo, Japan
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Email contact via H. Lundbeck A/S
LundbeckClinicalTrials@Lundbeck.com
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 3, 2020
First Posted
April 7, 2020
Study Start
April 1, 2020
Primary Completion
August 13, 2020
Study Completion
August 13, 2020
Last Updated
August 14, 2020
Record last verified: 2020-08