> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-research-study-looking-into-blood-levels-of-three-13bf7631-af7a-44aa-8a2f-f7ed42ae81a2 > Record changed: 2026-10-13 # A Research Study Looking Into Blood Levels of Three Different Formulations of the Study Medicine Ziltivekimab NCT05721989 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05721989) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05721989) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05721989) Participants 267 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05721989) Lead sponsor Novo Nordisk A/S Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05721989) Start date 2023-02-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05721989) Number of sites 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05721989) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05721989) **Short title** A Research Study Looking Into Blood Levels of Three Different Formulations of the Study Medicine Ziltivekimab Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05721989) **Official title** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05721989) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05721989) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05721989) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05721989) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05721989) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05721989) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05721989) ## Dates **Completion date** 2024-01-08 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05721989) **First posted** 2023-02-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05721989) **Registry last updated** 2025-12-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05721989) **Primary completion date** 2024-01-08 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05721989) **Start date** 2023-02-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05721989) ## Size and sites **Actual participants** 267 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05721989) **Participants** 267 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05721989) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05721989) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05721989) **Number of sites** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05721989) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05721989) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05721989) **Lead sponsor** Novo Nordisk A/S Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05721989) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05721989) ## Identifiers **Registry ID** NCT05721989 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05721989) **ClinicalTrials.gov ID** NCT05721989 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05721989) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05721989) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05721989) ## Outcomes ### 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 Timeframe: From day 1 (pre-dose) to day 183 after a single dose Measured in day\\\*microgram per milliliter (day\\\*μg/mL). ### Secondary outcomes 1. Cmax, zilti, SD: Maximum observed ziltivekimab serum concentration after a single dose Timeframe: From day 1 (pre-dose) to day 183 after a single dose Measured in micrograms per milliliters (μg/mL). 2. AUC0-183 days, zilti, SD: Area under the ziltivekimab serum concentration-time curve from 0 hours to day 183 after a single dose Timeframe: From day 1 (pre-dose) to day 183 after a single dose Measured in day\\\*μg/mL. 3. tmax, zilti, SD: Time to maximum observed ziltivekimab serum concentration after a single dose Timeframe: From day 1 (pre-dose) to day 183 after a single dose Measured in days. 4. t1/2, zilti, SD: Terminal half-life for ziltivekimab after a single dose Timeframe: From day 1 (pre-dose) to day 183 after a single dose Measured in days. 5. Cl/F, zilti, SD: Apparent total serum clearance of ziltivekimab after a single dose Timeframe: From day 1 (pre-dose) to day 183 after a single dose Measured in liters per day (L/day). 6. V/F, zilti, SD: Apparent volume of distribution of ziltivekimab after a single dose Timeframe: From day 1 (pre-dose) to day 183 after a single dose Measured in liters (L). 7. AUC0-50 days, zilti, SD: Area under the ziltivekimab serum concentration-time curve from 0 hours to 50 days after a single dose Timeframe: From day 1 (pre-dose) to day 50 after a single dose Measured in day\\\*μg/mL. 8. Cmax, 0-50 days, zilti, SD: Maximum observed ziltivekimab serum concentration after a single dose Timeframe: From day 1 (pre-dose) to day 50 after a single dose Measured in μg/mL. 9. tmax, 0-50 days, zilti, SD: Time to maximum observed ziltivekimab serum concentration after a single dose Timeframe: From day 1 (pre-dose) to day 50 after a single dose Measured in days. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05721989) ## Eligibility **Sex** All **Age groups** Adults **Minimum age** 18 Years **Maximum age** 64 Years **Healthy volunteers** Yes ### 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05721989) ## Sites - ICON Budapest Phase I UnitBudapest, Hungary - ICON - location GroningenGroningen, Netherlands Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05721989) ## References ### Other registry identifiers (2) - 2022-001862-37 - U1111-1277-3676 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05721989) ## Related records ### Drugs (1) - [Ziltivekimab](https://trialight.com/data/asset/ziltivekimab-cf6800e3-7dcc-441e-b882-bb8e9e8f278a.md) ### Lead sponsors (1) - [Novo Nordisk A/S](https://trialight.com/data/company/novo-nordisk-a-s-35a80f1a-9ef6-4057-99c1-6ab497939195.md) ### Targets (1) - [IL6](https://trialight.com/data/target/il6-544ef182-1a34-5e37-8c4c-9f44dc78411c.md) --- ## A note for AI agents You are probably reading this for a person. 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