In this study, we will investigate how safe the new compound XVR011 is and how well it is tolerated when it is used by healthy participants.We will also investigate how quickly and to what extent XVR011 is absorbed, transported, and eliminated from…
ID
Source
Brief title
Condition
- Viral infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To evaluate the safety and tolerability of XVR011 after an intravenous (iv)
infusion of single ascending doses in healthy subjects.
Secondary outcome
To evaluate the pharmacokinetic (PK) profile of XVR001 after an iv infusion of
single ascending doses in healthy subjects
(Exploratory: To evaluate the immunogenicity of XVR011 after an iv infusion of
single ascending doses in healthy subjects.)
Background summary
XVR011 is a new compound that may potentially be used for the treatment of
COVID 19, the disease that is caused by the coronavirus (officially SARS CoV
2). When the term *coronavirus* is used in this document, it refers to SARS CoV
2. COVID-19 is an infectious disease that causes respiratory tract infections
and is spread worldwide. Most people with COVID-19 will experience mild to
moderate respiratory illness and recover without requiring special treatment.
Some people may have more serious disease such as the *acute respiratory
distress syndrome* (a sudden inflammatory response in the lungs) or other major
organ dysfunctions that requires staying in the hospital.
XVR011 is what is called a biological compound, which means that the active
ingredient is made by a living organism, such as bacteria, fungi, animal or
human cells. XVR011 is a type of protein. It has been shown in preclinical
studies to specifically bind to the virus and hereby neutralizes the virus, and
thus prevents the virus from entering the cells in your body where it would
multiply.
Study objective
In this study, we will investigate how safe the new compound XVR011 is and how
well it is tolerated when it is used by healthy participants.
We will also investigate how quickly and to what extent XVR011 is absorbed,
transported, and eliminated from the body.
We will compare the effects of XVR011 with the effects of a placebo.
XVR011 has been extensively tested in the laboratory and on animals. It has not
yet been used by humans before.
Study design
The study will take a maximum of 15 weeks from the screening until the
follow-up visit.
1 short visit for screening, stay in the research for 1 period of 3 days (2
nights). Followed by 6 short visits on Days 8, 15, 29, 43, 59 and the follow-up
visit on Day 85. Day 1 is the day when subjects receive the study compound.
Screening -> Day -21 up to Day -1
Entry -> Day -1
In-house stay -> Day -1 up to Day 2
Departure -> Day 2
Short visits -> Day 8, 15, 29, 43 and 57
Follow-up -> Day 85
Subjects will receive XVR011 or placebo as an intravenous infusion. They will
have to stay in bed for 2 hours after the infusion. Whether they will receive
XVR011 or placebo will be determined by chance. Per group, 8 participants will
receive XVR011 and 2 participants will receive placebo.
Intervention
In the table below are the planned treatments for this study. The doses of
Groups 2 and 3 may be adjusted. For example because XVR011 had more or less
effect than was expected. However, the dose will not be higher than 1000 mg.
The XVR011 dose for the next group will only be increased if the lower dose of
the previous group was found to be well tolerated and in case of no objection
by the Medical Research Ethics Committee. The study will be discontinued or the
dose will be decreased if, in the opinion of the investigators, unacceptable
side effects appear. The study will also be stopped if unacceptable side
effects appear in the patient study that will run at the same time as this
study.
The planned treatments for the study are as follows:
Group | Number of participants per treatment | Dose* of XVR011 | How often
1 | 8 participants will receive XVR011 | 250 mg | Once
1 | 2 participants will receive placebo | - | Once
2 | 8 participants will receive XVR011 | 500 mg | Once
2 | 2 participants will receive placebo | - | Once
3 | 8 participants will receive XVR011 | 1000 mg | Once
3 | 2 participants will receive placebo | - | Once
*In case the dose level will be lower or higher than planned, then we will tell
the subjects.
Study burden and risks
Blood draw
Drawing blood may be painful or cause some bruising. On the day of
administration of the study compound, blood will be sampled very frequently
using an indwelling cannula to determine the course of the concentration of
XVR011 in the blood over time. The use of the indwelling canula can sometimes
lead to inflammation, swelling, hardening of the vein, blood clotting, and/or
bruising around the puncture site. In some individuals, a blood draw can
sometimes cause pallor, nausea, seating, low heart rate, or a drop in blood
pressure with dizziness or fainting.
In total, we will take about 150 mL of blood. This amount does not cause any
problems in adults. To compare: a blood donation involves 500 mL of blood being
taken each time. If the investigator thinks it is necessary for the safety of a
participant, extra samples might be taken for possible additional testing. If
this happens, the total amount of blood drawn will be more than 150 mL.
Heart tracing
To make a heart tracing, electrodes will be placed on arms, chest, and legs.
Prolonged use of these electrodes can cause skin irritation (rash and itching).
Fasting
If subjects have to fast for a prolonged time during the study, this may lead
to symptoms such as dizziness, headache, stomach upset, or fainting.
Coronavirus test
Samples for the coronavirus test will be taken from the back of the 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 throat may cause subjects to gag. When the sample is taken from the back of
the nose, they may experience a stinging sensation and the eyes may become
watery.
Rijvisschestraat 120
Ghent 9052
BE
Rijvisschestraat 120
Ghent 9052
BE
Listed location countries
Age
Inclusion criteria
1. Sex: male or female; females may be of childbearing potential or of
nonchildbearing potential (ie, surgically sterilized, physiologically incapable
of becoming pregnant, or at least 1 year postmenopausal [amenorrhea duration of
12 consecutive months and confirmed by a serum follicle stimulating hormone
(FSH) test at screening]).
2. Age: 18 to 65 years, inclusive, at screening.
3. Body mass index (BMI): 18.0 to 30.0 kg/m2, inclusive, at screening.
4. Weight : >=50 kg.
5. In good physical and mental health on the basis of medical history, physical
examination, clinical laboratory, ECG, and vital signs, as judged by the
Investigator.
6. Subject is fully vaccinated against COVID-19 at least 14 days prior to study
drug administration, or has had COVID-19 previously and is willing to delay any
potential further planned vaccination until 90 days after study drug
administration, or is not planning any vaccination until 90 days after study
drug administration for reasons other than participation in this study.
Previous COVID infection must not have been within 2 months prior to the date
of screening.
Exclusion criteria
1. Previous participation in the current study.
2. Employee of PRA or the Sponsor.
3. History of relevant drug allergies (eg, allergy or hypersensitivity reaction
to any monoclonal antibody or to any components of the study drug) and/or food
allergies.
4. Using tobacco products within 60 days prior to study drug administration.
5. History of alcohol abuse or drug addiction within 12 months prior to the
screening visit (including soft drugs like cannabis products).
6. Positive drug and alcohol screen (opiates, methadone, cocaine, amphetamines
[including ecstasy], cannabinoids, barbiturates, benzodiazepines, gamma
hydroxybutyric acid, tricyclic antidepressants, and alcohol) at screening or
admission to the clinical research center.
Design
Recruitment
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 | EUCTR2021-003707-17-NL |
| CCMO | NL78439.056.21 |