The purpose of the study is to investigate to what extent CEP-37248 is tolerated. Also investigated is how quickly and to what extent CEP-37248 is processed by the body (PK). In addition, the effect of the compound on how much IL-12 and IL-23 is in…
ID
Source
Brief title
Condition
- Autoimmune disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Safety, Tollerability
Secondary outcome
PK
Background summary
CEP-37248 is a new investigational compound that may eventually be used for the
treatment of autoimmune inflammatory diseases. Examples of autoimmune
inflammatory diseases are ulcerative colitis and Crohn*s disease, inflammatory
diseases of the intestine. CEP-37248 is a monoclonal antibody against two
proteins that are naturally found in the body, IL-12 and IL-23 (IL stands for
interleukin). Both proteins play a role in inflammation. CEP-37248 may prevent
IL-12/IL-23 function. As a result, inflammatory reactions are decreased. This
is the first time that this compound is being given to humans.
Study objective
The purpose of the study is to investigate to what extent CEP-37248 is
tolerated.
Also investigated is how quickly and to what extent CEP-37248 is processed by
the body (PK). In addition, the effect of the compound on how much IL-12 and
IL-23 is in the body and effects on the immune system will be investigated
(PD).
Study design
This study will be performed in 85 healthy male volunteers, divided into 9
groups. The study will be performed in each group separately; the groups will
start in the order in which they have been numbered. Group 1 will consist of 9
volunteers, Groups 6 and 8 will consist of 14 volunteers and all other groups
(Groups 2 to 5, Group 7 and Group 9) will consist of 8 volunteers.
Intervention
CEP-37248
Study burden and risks
As CEP-37248 will be administered to humans for the first time in this study,
adverse effects of CEP-37248 in humans have not been reported to date. However,
CEP-37248 has been studied in animals. In monkeys the drug was well-tolerated
and no adverse events were observed. No CEP-37248-related adverse effects were
seen up to the highest dose tested. Another similar drug, Stelara® or
ustekinumab * which is also a monoclonal antibody- is currently approved and
used by psoriasis patients. Since ustekinumab and CEP-37248 slow down the
activity of the immune system you may be more susceptible to infections. The
most common adverse reactions seen with ustekinumab are infections of the
breathing system and nasopharyngitis (common colds). These adverse effects are
generally mild. In case of subcutaneous administration a local reaction at the
site of the injection may occur. Any drug can cause allergic reactions; true
allergic reactions are unlikely since you will not have been previously exposed
to the drug or a similar drug. Hypersensitivity can occur during intravenous
administration.
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Listed location countries
Age
Inclusion criteria
Healthy males
18 -45 years
BMI of 18.0 to 30.0 kg/m2
Weight at least 50 kg
Exclusion criteria
Suffering from: hepatitis B, cancer or HIV/AIDS. In case of participation in another drug study within 60 days before the start of this study or being a blood donor within 90 days from the start of the study. In case of donating more than 1.5 liters of blood in the 10 months prior the start of this study.
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 | EUCTR2013-002587-61-NL |
| CCMO | NL45784.056.13 |