Safety, Tolerability and Pharmacokinetics of Eptinezumab in Healthy Chinese Subjects

Healthy Clinical Trial

Official title:

Interventional, Single-ascending-dose Study Investigating the Safety, Tolerability, and Pharmacokinetic Properties of Eptinezumab in Healthy Chinese Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05045781
• Other study ID #: 19004A
• Status: Completed
• Phase: Phase 1
• Start date: April 20, 2021
• Est. completion date: July 20, 2021

Study information

• Verified date: September 2021
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 20, 2021
• Est. primary completion date: July 20, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Eptinezumab
single iv infusion

Locations

Country	Name	City	State
China	zs-hospital Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Country where clinical trial is conducted

China, 

Outcome

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