Clinical trial NCT05721989: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2023-02-10
Enrollment: 267
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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
Secondary outcomes:
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: ICON Budapest Phase I Unit
city: Groningen
country: Netherlands
facility: ICON - location Groningen
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 2834)
role: STUDY_DIRECTOR
References: