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

• Status: Not yet recruiting
• Trial end date: 2024-03-18
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Novo Nordisk A/S

Criteria

Inclusion Criteria:

• Male or female

• Aged 18-64 years (both inclusive) at the time of signing informed consent.

• Body mass index (BMI) between 18.5 and 29.9 kilograms per square meter (kg/m^2) (both inclusive).

• Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.

Exclusion Criteria:

• Known or suspected hypersensitivity to study intervention(s) or related products.

• Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method.

• Any disorder which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.

• Use of prescription medicinal products or non-prescription drugs, except routine vitamins, topical medication, highly effective contraceptives and occasional use of paracetamol, acetylsalicylic acid within 14 days before trial product administration.

• Clinical evidence of, or suspicion of, active infection at the discretion of the investigator.