NCT05045781

Brief Summary

The purpose of the study is to investigate how the body absorbs and get rid of eptinezumab when given directly into a vein in Chinese subjects.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 20, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 7, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 16, 2021

Completed
Last Updated

September 16, 2021

Status Verified

September 1, 2021

Enrollment Period

3 months

First QC Date

September 7, 2021

Last Update Submit

September 7, 2021

Conditions

Healthy

Outcome Measures

Primary Outcomes (5)

  • AUC(0-inf) eptinezumab

    Area under the plasma concentration-time curve

    Day 1 to Day 84

  • Maximal observed plasma concentration (Cmax) of eptinezumab

    Day 1 to Day 84

  • Systemic clearance (CL) of eptinezumab

    Eptinezumab dose/AUC(0-inf)

    Day 1 to Day 84

  • tmax

    Nominal time for the occurrence of Cmax (tmax)

    Day 1 to Day 84

  • Apparent terminal elimination half-life (t½)

    Day 1 to Day 84

Study Arms (2)

Eptinezumab 100 mg

EXPERIMENTAL
Drug: Eptinezumab

Eptinezumab 300 mg

EXPERIMENTAL
Drug: Eptinezumab

Interventions

EptinezumabDRUG

single iv infusion

Eptinezumab 100 mgEptinezumab 300 mg

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI of ≥ 19 and ≤ 25 kg/m2.
  • The subject is Chinese, defined as being born in China and having four Chinese grandparents.
  • The subject is, in the opinion of the investigator, generally healthy based on medical history, a physical examination, vital signs, an ECG, and the results of the clinical chemistry, haematology, urinalysis, serology, and other laboratory tests.

You may not qualify if:

  • The subject is pregnant or breastfeeding.
  • The subject has or has had any clinically significant immunological, cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, or psychiatric disease or other major disorder.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

zs-hospital Shanghai

Shanghai, China

Location

MeSH Terms

Interventions

eptinezumab

Study Officials

  • Email contact via H. Lundbeck A/S

    LundbeckClinicalTrials@Lundbeck.com

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2021

First Posted

September 16, 2021

Study Start

April 20, 2021

Primary Completion

July 20, 2021

Study Completion

July 20, 2021

Last Updated

September 16, 2021

Record last verified: 2021-09

Locations

CN(1)