A Research Study Looking Into Blood Levels of Three Different Formulations of the Study Medicine Ziltivekimab
- 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.
- Short title
- A Research Study Looking Into Blood Levels of Three Different Formulations of the Study Medicine Ziltivekimab
- 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
- Control arm
- Open label
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2024-01-08
- First posted
- 2023-02-10
- Registry last updated
- 2025-12-30
- Primary completion date
- 2024-01-08
- Start date
- 2023-02-03
- Actual participants
- Participants
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Novo Nordisk A/S
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT05721989
- ClinicalTrials.gov ID
- NCT05721989
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- No masking
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).
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).
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.
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.
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.
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).
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).
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.
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.
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.
- Sex
- All
- Age groups
- Adults
- Minimum age
- 18 Years
- Maximum age
- 64 Years
- Healthy volunteers
- Yes
- 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.
- 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.
- ICON Budapest Phase I UnitBudapest, Hungary
- ICON - location GroningenGroningen, Netherlands
- 2022-001862-37
- U1111-1277-3676