NCT05721989

A Research Study Looking Into Blood Levels of Three Different Formulations of the Study Medicine Ziltivekimab

A Comparative Bioavailability Study of a Single Dose of Ziltivekimab Formulation B in a Manual Syringe, Formulation D in a Manual Syringe and Formulation C in a Pen-injector

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 267 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

Summary

A research study to investigate how quickly and to what extent different compositions of the study medicine ziltivekimab are absorbed, transported, and eliminated from the body. Ziltivekimab is not yet approved for market. The study medicine will be injected under the skin (this is called subcutaneous administration). Two different administration methods will be compared: a syringe and a pen-injector. A pen-injector is a device that is developed to make injections more easy and convenient. They are for example used by diabetes patients to inject insulin. It will also be investigated how safe ziltivekimab is and how well it is tolerated when it is used by healthy participants. Ziltivekimab has already been administered to patients with chronic kidney disease or rheumatoid arthritis. The current study will be the first study where ziltivekimab will be given to healthy participants.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	Ziltivekimab B	Participants will receive a single s.c. injection of 15 mg ziltivekimab B (15 mg/mL) by single-use pre-filled manual syringe on Day 1.
DRUG	Ziltivekimab D	Participants will receive a single s.c. injection of 15 mg ziltivekimab D (15 mg/mL) by single-use pre-filled manual syringe on Day 1.
DRUG	Ziltivekimab C	Participants will receive a single s.c. injection of 15 mg ziltivekimab C (30 mg/mL) by single-use pre-filled syringe assembled into a shield-activated pen-injector on Day 1.

Timeline

• Start date: 2023-02-03
• Primary completion: 2024-01-08
• Completion: 2024-01-08
• First posted: 2023-02-10
• Last updated: 2025-12-30

Locations

2 sites across 2 countries: Hungary, Netherlands