Ziltivekimab B
DrugParticipants 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.
NCT Number: NCT05721989
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.
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Notify Me18 year–64 year
All sexes
Interventional
Phase 1
ICON Budapest Phase I Unit, Budapest, Hungary
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
Time frame: From day 1 (pre-dose) to day 183 after a single dose
Measured in day*microgram per milliliter (day*μg/mL).
Time frame: From day 1 (pre-dose) to day 183 after a single dose
Measured in micrograms per milliliters (μg/mL).
Time frame: From day 1 (pre-dose) to day 183 after a single dose
Measured in day*μg/mL.
Time frame: From day 1 (pre-dose) to day 183 after a single dose
Measured in days.
Time frame: From day 1 (pre-dose) to day 183 after a single dose
Measured in days.
Time frame: From day 1 (pre-dose) to day 183 after a single dose
Measured in liters per day (L/day).
Time frame: From day 1 (pre-dose) to day 183 after a single dose
Measured in liters (L).
Time frame: From day 1 (pre-dose) to day 50 after a single dose
Measured in day*μg/mL.
Time frame: From day 1 (pre-dose) to day 50 after a single dose
Measured in μg/mL.
Time frame: From day 1 (pre-dose) to day 50 after a single dose
Measured in days.
Novo Nordisk A/S
Industry
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
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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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