Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2022-001862-37 | EudraCT Number | ||
| U1111-1277-3676 | Other Identifier | World Health Organization (WHO) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (dept. 2834) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICON Budapest Phase I Unit | Budapest | 1077 | Hungary | |||
| ICON - location Groningen |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 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. |
|
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 |
| Groningen |
| 9728 NZ |
| Netherlands |