Healthy ParticipantsPhase 1NCT05721989
A Research Study Looking Into Blood Levels of Three Different Formulations of the Study Medicine Ziltivekimab
A Phase 1 study testing Ziltivekimab B, Ziltivekimab D and Ziltivekimab C in people with Healthy Participants, run by Novo Nordisk A/S at 2 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Ziltivekimab B, Ziltivekimab D and Ziltivekimab C
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 267 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 3 Feb 2023to 8 Jan 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
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
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
- Being tested
- Ziltivekimab B, Ziltivekimab D, Ziltivekimab C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ziltivekimab BDrug
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 DDrug
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 CDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: Ziltivekimab C |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Measured in micrograms per milliliters (μg/mL).
Measured: 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
Measured in day*μg/mL.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From day 1 (pre-dose) to day 50 after a single dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2023
- Study start3 Feb 2023
- Primary completion8 Jan 2024
- Study completion8 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 267 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency (dept. 2834), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05721989
- Sponsor's protocol ID
- NN6018-4951
- Other IDs
- 2022-001862-37, U1111-1277-3676
- Status last verified
- Dec 2025
- First submitted
- 1 Feb 2023
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05721989
- Acronym / sponsor ID
- NN6018-4951
- Conditions
- Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 267 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 3 Feb 2023 (actual)
- Primary completion
- 8 Jan 2024 (actual)
- Study completion
- 8 Jan 2024 (actual)
- First posted
- 10 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ziltivekimab B (manual syringe) | Experimental | Drug: Ziltivekimab BParticipants 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 | Drug: Ziltivekimab DParticipants 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 | Drug: Ziltivekimab CParticipants 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. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ziltivekimab BParticipants 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. | Drug | Ziltivekimab B (manual syringe) |
| Ziltivekimab DParticipants 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 (manual syringe) |
| Ziltivekimab CParticipants 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 (pen-injector) |
Primary outcome
AUC0-inf, zilti, SD: Area under the ziltivekimab serum concentration-time curve from 0 hours and extrapolated to infinity after a single dose
Time frame: From day 1 (pre-dose) to day 183 after a single dose
Measured in day*microgram per milliliter (day*μg/mL).
9 secondary outcomes
Cmax, zilti, SD: Maximum observed ziltivekimab serum concentration after a single dose
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From day 1 (pre-dose) to day 50 after a single dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2025.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Transparency (dept. 2834) study director
Novo Nordisk A/S
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ziltivekimab B, Ziltivekimab D and Ziltivekimab C in people with Healthy Participants, run by Novo Nordisk A/S at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Hungary, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC0-inf, zilti, SD: Area under the ziltivekimab serum concentration-time curve from 0 hours and extrapolated to infinity after a single dose (time frame: From day 1 (pre-dose) to day 183 after a single dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2025.