drugset / Trial / NCT05721989

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

NCT05721989 ↗

Phase 1 Completed 267 enrolled Novo Nordisk A/S
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2023-02-03
Primary completion
2024-01-08
Completion
2024-01-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Ziltivekimab Monoclonal antibody 15 mg Subcutaneous

Indications

No indication recorded.