Safety, Tolerability and Pharmacokinetics of Eptinezumab in Healthy Chinese Subjects

• Sponsor: H. Lundbeck A/S (Industry)
• Overall Status: Completed
• CT.gov ID: NCT05045781
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Actual Duration (Months): 3
• Patients Per Site Per Month: 6.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Eptinezumab	Phase 1

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 Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Interventional, Single-ascending-dose Study Investigating the Safety, Tolerability, and Pharmacokinetic Properties of Eptinezumab in Healthy Chinese Subjects
• Actual Study Start Date: Apr 20, 2021
• Actual Primary Completion Date: Jul 20, 2021
• Actual Study Completion Date: Jul 20, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Eptinezumab 100 mg	Drug: Eptinezumab; single iv infusion
Experimental: Eptinezumab 300 mg	Drug: Eptinezumab; single iv infusion

Outcome Measures

Primary Outcome Measures

1. AUC(0-inf) eptinezumab [Day 1 to Day 84]

   Area under the plasma concentration-time curve

2. Maximal observed plasma concentration (Cmax) of eptinezumab [Day 1 to Day 84]

3. Systemic clearance (CL) of eptinezumab [Day 1 to Day 84]

   Eptinezumab dose/AUC(0-inf)

4. tmax [Day 1 to Day 84]

   Nominal time for the occurrence of Cmax (tmax)

5. Apparent terminal elimination half-life (t½) [Day 1 to Day 84]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	zs-hospital Shanghai	Shanghai		China

Sponsors and Collaborators

• H. Lundbeck A/S

Investigators

• Study Director: Email contact via H. Lundbeck A/S, [e-mail]

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: H. Lundbeck A/S
• ClinicalTrials.gov Identifier: NCT05045781
• Other Study ID Numbers: 19004A
• First Posted: Sep 16, 2021
• Last Update Posted: Sep 16, 2021
• Last Verified: Sep 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Sep 16, 2021