Eptinezumab in Healthy Japanese Subjects
Sponsor
H. Lundbeck A/S (Industry)
Overall Status
Completed
CT.gov ID
NCT04336449
Collaborator
(none)
18
1
3
4.4
4.1
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Detailed Description
The study will consist of 18 healthy Japanese subjects, divided into two single dose cohorts with 9 subjects in each cohort.
Study Design
Study Type:
Interventional
Actual Enrollment
:
18 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Interventional, Randomized, Double-blind, Placebo-controlled, Single-ascending-dose Study Investigating the Safety, Tolerability, and Pharmacokinetic Properties of Eptinezumab in Healthy Japanese Subjects
Actual Study Start Date
:
Apr 1, 2020
Actual Primary Completion Date
:
Aug 13, 2020
Actual Study Completion Date
:
Aug 13, 2020
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Cohort 1 100 mg eptinezumab
|
Drug: Eptinezumab
Eptinezumab - single intravenous infusion
|
| Experimental: Cohort 2 300 mg eptinezumab
|
Drug: Eptinezumab
Eptinezumab - single intravenous infusion
|
| Placebo Comparator: Placebo
|
Drug: Placebo
Placebo - single intravenous infusion
|
Outcome Measures
Primary Outcome Measures
- 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]
Eligibility Criteria
Criteria
Ages Eligible for Study:
20 Years
to 55 Years
Sexes Eligible for Study:
All
Accepts 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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | P-One Clinic | Tokyo | Japan |
Sponsors and Collaborators
- H. Lundbeck A/S
Investigators
- Study Director: Email contact via H. Lundbeck A/S, LundbeckClinicalTrials@Lundbeck.com
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
H. Lundbeck A/S
ClinicalTrials.gov Identifier:
NCT04336449
Other Study ID Numbers:
- 18899A
First Posted:
Apr 7, 2020
Last Update Posted:
Aug 14, 2020
Last Verified:
Aug 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No