In this study we will investigate how safe the new compound Ent001 is and how well it is tolerated when it is used by healthy subjects.We also investigate how quickly and to what extent Ent001 is absorbed, transported, and eliminated from the body (…
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
- Diabetic complications
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To evaluate the safety and tolerability of single ascending doses (SAD) of
Ent001 in adult healthy male and female subjects
Secondary outcome
To evaluate the pharmacokinetics (PK) of SAD of Ent001 in adult healthy male
and female subjects
To assess the presence of antidrug antibodies (ADAs) against Ent001 following
SAD of Ent001 in adult healthy male and female subjects
Background summary
Ent001 is a new compound that may potentially be used for the treatment of type
1 diabetes and inflammatory bowel disease (ulcerative colitis). Ent001 works by
inhibiting the TMEM219 receptor which is present on certain cells of the
pancreas, colon and other organs. The inhibition of this receptor has a
protective effect on these cells. In the case of type 1 diabetes this could
result in more cells that produce insulin and therefor reduce the effects of
the diabetes. In the case of inflammatory bowel disease more colon cells can be
preserved which could reduce the burden of disease.
Study objective
In this study we will investigate how safe the new compound Ent001 is and how
well it is tolerated when it is used by healthy subjects.
We also investigate how quickly and to what extent Ent001 is absorbed,
transported, and eliminated from the body (this is called pharmacokinetics). In
addition, we look at the effect of Ent001 on some substances and cells in the
blood (this is called pharmacodynamics).
We compare the effects of Ent001 with the effects of a placebo. A placebo is a
compound without any active ingredient. Please note that when the term *study
compound* is used in this document, we mean Ent001, placebo, or both.
Ent001 has not been administered to humans before. It has been extensively
tested in the laboratory and on animals.
Study design
The study will take a maximum of 18 weeks from the screening until the
follow-up visit.
In total the volunteer will visit the research center 14 times:
- once for the screening.
- once for the volunteers stay in the research center. For the study it is
necessary that the volunteer stay in the research center for 1 period of 5 days
(4 nights). The volunteers are expected at the research center the day before
the day of administration of the study compound. The volunteer has to be at the
research center between 9:30 hrs and 14:00 hrs. Prior to entry into the
research center the volunteer will be notified of the exact time. Day 1 is the
day when the volunteer receive the study compound. The volunteer will leave the
research center on Day 4 of the study.
- 11 times for short visits and one time for the follow-up visit. After the
volunteers stay in the research center there will be 11 short visits to the
research center. These short visits will take place on Days 5, 8, 10, 14, 21,
28, 35, 42, 56, 70 and 84. The follow-up visit will take place on Day 98.
The volunteer will be given Ent001 or placebo as an intravenous infusion
(solution of the compound that will be administered directly in a blood
vessel).
Whether the volunteer will receive Ent001 or placebo will be determined by
chance. Per group, 4 subjects will receive Ent001 and 2 subjects will receive
placebo.
Intervention
Group Day Treatment How often Dosing form
1 1 Ent001 0.15 mg/kg or placebo Once Infusion into the bloodstream
(intravenous infusion)
2 Ent001 0.5 mg/kg or placebo
3 Ent001 1.7 mg/kg or placebo
4 Ent001 5 mg/kg or placebo
5 Ent001 10 mg/kg or placebo
Study burden and risks
possible discomforts:
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 345 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. To monitor the electrical activity of your
heart over a longer period, electrodes (small, plastic patches) will be placed
on the chest and abdomen. Prolonged use of these electrodes can cause skin
irritation (rash and itching).
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.
Via V. Gioberti 8
Milano 20122
IT
Via V. Gioberti 8
Milano 20122
IT
Listed location countries
Age
Inclusion criteria
1. Sex: male or female; females must be of nonchildbearing potential or
postmenopausal.
2. Age: 18 to 65 years, inclusive, at screening.
3. Body mass index: 18.0 kg/m2 to 30.0 kg/m2, inclusive, at screening.
Calculated as body weight (kg) divided by height (m)2.
4. Weight: >=50 kg at screening.
5. Status: healthy subjects.
Further criteria apply
Exclusion criteria
1. Previous participation in the current study.
2. Employee of ICON or the Sponsor.
3. History of sensitivity to any of the study treatments, or components
thereof, or any clinically significant history of allergic conditions as judged
by the Investigator (including drug allergies, asthma, eczema, or anaphylactic
reactions, but excluding untreated, asymptomatic, seasonal allergies at the
time of dosing).
4. The subjects who have had a prior allergic reaction, including anaphylaxis,
to any other human, humanized, chimeric, or rodent antibodies.
5. Using tobacco products within 3 months prior to dosing.
Further criteria apply
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 | EUCTR2022-002176-37-NL |
| CCMO | NL82057.056.22 |