In this study we will look at the blood levels of the study compound ziltivekimab. We will investigate how quickly and to what extent different compositions of ziltivekimab are absorbed, transported, and eliminated from the body. Ziltivekimab is not…
ID
Source
Brief title
Condition
- Cardiac and vascular disorders congenital
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To compare the pharmacokinetic properties of a single s.c. administration of
ziltivekimab in formulation B for the manual syringe, formulation D for the
manual syringe, and formulation C for the pen-injector
Secondary outcome
To compare the pharmacokinetic properties of a single s.c. administration of
ziltivekimab in formulation B for the manual syringe, formulation D for the
manual syringe, and formulation C for the pen-injector, 50 days following
dosing
Background summary
Ziltivekimab is a new compound that may potentially be used for the treatment
of cardiovascular diseases. Ziltivekimab is an antibody that can bind a protein
in the body called interleukin 6 (IL-6). IL-6 is a protein that plays an
important role in inflammation processes and is involved in cardiovascular
diseases such as arteriosclerosis and stroke. By binding to IL-6, ziltivekimab
aims to reduce inflammation and thereby potentially reduce the risk for
cardiovascular diseases.
The study compound remains in the body for a long time. The half-life, that is
the time it takes for the amount of the study compound in the blood to be
halved, is approximately 57 days for ziltivekimab. This is why you have to
return to the research center for visits over a long period.
Study objective
In this study we will look at the blood levels of the study compound
ziltivekimab. We will investigate how quickly and to what extent different
compositions of ziltivekimab are absorbed, transported, and eliminated from the
body. Ziltivekimab is not yet approved for market. Ziltivekimab is hereinafter
also referred to as *study compound*.
The study compound will be injected under the skin (this is called subcutaneous
administration) of the abdomen. We will compare two different administration
methods: 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.
We will also investigate how safe ziltivekimab is and how well it is tolerated
when it is used by healthy subjects.
Ziltivekimab has already been administered to patients with chronic kidney
disease or rheumatoid arthritis. It has only been given to patients in a
research setting. The current study will be the first study where ziltivekimab
will be given to healthy subjects.
Study design
The study will take a total of about 31 weeks (about 7 months) from the
screening until the follow-up visit.
In total the volunteer will come to the research center 16 times:
- once for the screening as described before, which will take place within 28
days before dosing.
- A visit to the research center on the day before dosing of the study compound
(Day -1).
- A visit to the research center during which the study compound will be
administered (Day 1). The volunteer will leave the research center
approximately 2 to 4 hours after receiving the study compound.
- 12 visits after administration of the study compound. These visits will take
place on Day 2, 3, 5, 8, 15, 22, 29, 36, 50, 71, 99, and 141.
- A follow-up visit on Day 183.
Intervention
The volunteer will be given ziltivekimab as an injection under the skin
(subcutaneous) of the abdomen.
There are 3 different study treatments in this study. The volunteer will
receive 1 of them. Which study treatment the volunteer will receive will be
determined by drawing lots. the volunteer will have a 33.3% chance of receiving
each study treatment . Both the volunteer and the study staff will know which
study treatment the volunteer will receive.
Below you can see the 3 possible study treatments:
- Ziltivekimab B, injected with a manual syringe
- Ziltivekimab D, injected with a manual syringe
- Ziltivekimab C, injected with a pen-injector
The volunteer will receive a single dose of 15 milligram ziltivekimab on Day 1.
Study burden and risks
Blood draw
Drawing blood may be painful or cause some bruising. The use of the indwelling
cannula (a tube in a vein in the arm) can sometimes lead to inflammation,
swelling, hardening of the vein, blood clotting, and bleeding in the
environment (bruising) of the puncture site. In some individuals, a blood draw
can sometimes cause pallor, nausea, sweating, low heart rate, or drop in blood
pressure with dizziness or fainting.
In total, we will take about 168 milliliters (mL) of blood from the volunteer
from screening to follow-up. This amount does not cause any problems in adults.
To compare: a blood donation involves 500 mL of blood being taken each time at
once. If the investigator thinks it is necessary for the safety of a subject,
extra samples might be taken for possible additional testing. If this happens,
the total amount of blood drawn may be more than the amount indicated above.
Heart tracing
To make a heart tracing, electrodes (small, plastic patches) will be placed on
the volunteers arms, chest and legs. Prolonged use of these electrodes can
cause skin irritation (rash and itching). Any skin irritation usually
disappears when the patches are removed.
Coronavirus test
Samples for the coronavirus test will be taken from the back of the volunteers
nose and throat using swabs. Taking the samples only takes a few seconds, but
can cause discomfort and can give an unpleasant feeling. Taking a sample from
the back of the volunteers throat may cause the volunteer to gag. When the
sample is taken from the back of the volunteers nose, the volunteer may
experience a stinging sensation and the volunteers eyes may become watery.
If there is an outbreak of COVID-19 in your area, then the research center will
take actions to minimize any risk of transmission and inform the volunteer
about these changes.
Injections
When using a syringe or pen-injector to inject the study compound under the
skin, this may cause a little discomfort, bruising, bleeding or swelling where
the needle goes in. There is also a very small risk of infection where the
needle goes in.
Novo Alle 1
Bagsværd 2880
DK
Novo Alle 1
Bagsværd 2880
DK
Listed location countries
Age
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 kg/m2 (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, as defined in section
10.4.
- 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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2022-001862-37-NL |
| CCMO | NL83434.056.22 |