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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Participants
• Intervention / Treatment: Drug: Ziltivekimab B; Drug: Ziltivekimab D; Drug: Ziltivekimab C

• Study Type: Interventional
• Enrollment (Actual): 267
• Phase: Phase 1

Contacts and Locations

Study Locations

• Hungary
  • Budapest, Hungary, 1077
    • ICON Budapest Phase I Unit
• Netherlands
  • Groningen, Netherlands, 9728 NZ
    • ICON - location Groningen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ziltivekimab B (manual syringe); Participants will receive a single subcutaneous (s.c.) injection of 15 milligram (mg) ziltivekimab B (15 milligrams per milliliter [mg/mL]) by single-use pre-filled manual syringe on Day 1.	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.
Experimental: Ziltivekimab D (manual syringe); 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 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.
Experimental: Ziltivekimab C (pen-injector); 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC0-inf, zilti, SD: Area under the ziltivekimab serum concentration-time curve from 0 hours and extrapolated to infinity after a single dose	Measured in day*microgram per milliliter (day*μg/mL).	From day 1 (pre-dose) to day 183 after a single dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax, zilti, SD: Maximum observed ziltivekimab serum concentration after a single dose	Measured in micrograms per milliliters (μg/mL).	From day 1 (pre-dose) to day 183 after a single dose
AUC0-183 days, zilti, SD: Area under the ziltivekimab serum concentration-time curve from 0 hours to day 183 after a single dose	Measured in day*μg/mL.	From day 1 (pre-dose) to day 183 after a single dose
tmax, zilti, SD: Time to maximum observed ziltivekimab serum concentration after a single dose	Measured in days.	From day 1 (pre-dose) to day 183 after a single dose
t1/2, zilti, SD: Terminal half-life for ziltivekimab after a single dose	Measured in days.	From day 1 (pre-dose) to day 183 after a single dose
Cl/F, zilti, SD: Apparent total serum clearance of ziltivekimab after a single dose	Measured in liters per day (L/day).	From day 1 (pre-dose) to day 183 after a single dose
V/F, zilti, SD: Apparent volume of distribution of ziltivekimab after a single dose	Measured in liters (L).	From day 1 (pre-dose) to day 183 after a single dose
AUC0-50 days, zilti, SD: Area under the ziltivekimab serum concentration-time curve from 0 hours to 50 days after a single dose	Measured in day*μg/mL.	From day 1 (pre-dose) to day 50 after a single dose
Cmax, 0-50 days, zilti, SD: Maximum observed ziltivekimab serum concentration after a single dose	Measured in μg/mL.	From day 1 (pre-dose) to day 50 after a single dose
tmax, 0-50 days, zilti, SD: Time to maximum observed ziltivekimab serum concentration after a single dose	Measured in days.	From day 1 (pre-dose) to day 50 after a single dose

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S
• Investigators: Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2023
• Primary Completion (Actual): January 8, 2024
• Study Completion (Actual): January 8, 2024

Study Registration Dates

• First Submitted: February 1, 2023
• First Submitted That Met QC Criteria: February 1, 2023
• First Posted (Actual): February 10, 2023

Study Record Updates

• Last Update Posted (Actual): December 30, 2025
• Last Update Submitted That Met QC Criteria: December 22, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: NN6018-4951; 2022-001862-37 (EudraCT Number); U1111-1277-3676 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No