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

NCT05721989 | Completed Phase 1

• 3 other identifiers: NN6018-49512022-001862-37U1111-1277-3676
• Study Type: interventional
• Target: 267
• Locations: 2 countries
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Cmax, zilti, SD: Maximum observed ziltivekimab serum concentration after a single dose

  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

  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

  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

  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

  From day 1 (pre-dose) to day 183 after a single dose

Study Arms (3)

Ziltivekimab B (manual syringe)

EXPERIMENTAL

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

Ziltivekimab D (manual syringe)

EXPERIMENTAL

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

Ziltivekimab C (pen-injector)

EXPERIMENTAL

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

Interventions

Ziltivekimab B DRUG

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.

Ziltivekimab B (manual syringe)

Ziltivekimab D DRUG

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.

Ziltivekimab D (manual syringe)

Ziltivekimab C DRUG

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.

Ziltivekimab C (pen-injector)

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (2)

ICON Budapest Phase I Unit

Budapest, 1077, Hungary

Location

ICON - location Groningen

Groningen, 9728 NZ, Netherlands

Location

Study Officials

• Clinical Transparency (dept. 2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2023
• First Posted: February 10, 2023
• Study Start: February 3, 2023
• Primary Completion: January 8, 2024
• Study Completion: January 8, 2024
• Last Updated: December 30, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

NL (1); HU (1)