Healthy Participants
Conditions
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.
Interventions
DRUGZiltivekimab 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.
DRUGZiltivekimab 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.
DRUGZiltivekimab 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.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUC0-inf, zilti, SD: Area under the ziltivekimab serum concentration-time curve from 0 hours and extrapolated to infinity after a single dose | From day 1 (pre-dose) to day 183 after a single dose | Measured in day\*microgram per milliliter (day\*μg/mL). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Measured in day\*μg/mL. |
| 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 | Measured in days. |
| 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 | Measured in days. |
| 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 | Measured in liters per day (L/day). |
| Cmax, zilti, SD: Maximum observed ziltivekimab serum concentration after a single dose | From day 1 (pre-dose) to day 183 after a single dose | Measured in micrograms per milliliters (μg/mL). |
| AUC0-50 days, zilti, SD: Area under the ziltivekimab serum concentration-time curve from 0 hours to 50 days after a single dose | 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 | 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 | From day 1 (pre-dose) to day 50 after a single dose | Measured in days. |
| V/F, zilti, SD: Apparent volume of distribution of ziltivekimab after a single dose | From day 1 (pre-dose) to day 183 after a single dose | Measured in liters (L). |
Countries
Hungary, Netherlands
Outcome results
None listed