Safety, Tolerability and Pharmacokinetics of Eptinezumab in Healthy Chinese Subjects

NCT ID: NCT05045781

Last Updated: 2021-09-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-20
• Study Completion Date: 2021-07-20

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Eptinezumab 100 mg

Group Type: EXPERIMENTAL

Eptinezumab

Intervention Type: DRUG

single iv infusion

Eptinezumab 300 mg

Group Type: EXPERIMENTAL

Eptinezumab

Intervention Type: DRUG

single iv infusion

Interventions

Eptinezumab

single iv infusion

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

H. Lundbeck A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Email contact via H. Lundbeck A/S

Role: STUDY_DIRECTOR

LundbeckClinicalTrials@Lundbeck.com

Locations

zs-hospital Shanghai

Shanghai, , China

Countries

China

Other Identifiers

19004A

Identifier Type: -

Identifier Source: org_study_id