Safety, Tolerability and Pharmacokinetics of Eptinezumab in Healthy Chinese Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Eptinezumab

• Registration Number: NCT05045781
• Lead Sponsor: H. Lundbeck A/S

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.

Detailed Description

This is an interventional, randomized, open-label, parallel-group, single-dose study investigating the safety, tolerability and pharmacokinetic properties of eptinezumab administered by intravenous (iv) infusion.

The study will consist of 20 healthy Chinese subjects, who will be randomized into two single-dose groups. The two groups will be run in parallel. In Group 1, a total of 10 subjects will receive a single iv infusion of 100 mg eptinezumab on Day 1. In Group 2, a total of 10 subjects will receive a single iv infusion of 300 mg eptinezumab on Day 1.

Safety and tolerability will be assessed throughout the study. Blood samples for plasma quantification of free eptinezumab will be collected from Day 1 to the Completion Visit (Day 84)/Withdrawal Visit.

Study Timeline

• Study Start: 2021-04-20
• Primary Completion: 2021-07-20
• Study Completion: 2021-07-20
• Status Verified: 2021-09
• Study First Submitted: 2021-09-07
• Study First Submitted QC: 2021-09-07
• Last Update Submitted: 2021-09-07
• Study First Posted: 2021-09-16
• Last Update Posted: 2021-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Other inclusion and exclusion criteria may apply

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Eptinezumab 300 mg	Eptinezumab	-
Eptinezumab 100 mg	Eptinezumab	-

Primary Outcome Measures

Name	Time	Method
tmax	Day 1 to Day 84	Nominal time for the occurrence of Cmax (tmax)
AUC(0-inf) eptinezumab	Day 1 to Day 84	Area under the plasma concentration-time curve
Apparent terminal elimination half-life (t½)	Day 1 to Day 84
Maximal observed plasma concentration (Cmax) of eptinezumab	Day 1 to Day 84
Systemic clearance (CL) of eptinezumab	Day 1 to Day 84	Eptinezumab dose/AUC(0-inf)

Trial Locations

Locations (1)

zs-hospital Shanghai; 🇨🇳 Shanghai, China