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Completed

NCT Number: NCT05045781

Safety, Tolerability and Pharmacokinetics of Eptinezumab in Healthy Chinese Subjects

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.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

zs-hospital Shanghai

Shanghai, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Eptinezumab

Drug

single iv infusion

Primary outcomes

  1. AUC(0-inf) eptinezumab

    Time frame: Day 1 to Day 84

    Area under the plasma concentration-time curve

  2. Maximal observed plasma concentration (Cmax) of eptinezumab

    Time frame: Day 1 to Day 84

  3. Systemic clearance (CL) of eptinezumab

    Time frame: Day 1 to Day 84

    Eptinezumab dose/AUC(0-inf)

  4. tmax

    Time frame: Day 1 to Day 84

    Nominal time for the occurrence of Cmax (tmax)

  5. Apparent terminal elimination half-life (t½)

    Time frame: Day 1 to Day 84

Sponsors and collaborators

Lead sponsor

H. Lundbeck A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Sep 16, 2021
Registry last updated
Sep 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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