The purpose of this research study is to investigate how safe the compound is and how well the compound is tolerated. The study will also investigate how quickly and to what extent the compound is absorbed and eliminated from the body (this is…
ID
Source
Brief title
Condition
- Autoimmune disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Pharmacodynamics : Pharmacodynamics parameters
Pharmacokinetics : Pharmacokinetic parameters
Safety : TEAEs, local tolerability assessment, clinical laboratory and vital
signs
Secondary outcome
n/a
Background summary
MSB0010841 is an experimental drug that may eventually be used for the
treatment of several autoimmune diseases. An autoimmune disease is an illness
that occurs when the body tissues are attacked by its own immune system. This
occurs for example in rheumatoid arthritis and psoriasis patients.
MSB0010841 is a drug made of 3 so-called nanobodies. A nanobody is a very small
fragment of an antibody. Antibodies are produced by our own body for host
defense against for example bacteria and viruses. However, antibodies can also
be prepared in a custom made way by pharmaceutical companies, so that they can
be used for medical research and various therapeutical applications.
MSB0010841 is constructed in such a way that it can recognize, bind
specifically to and block the function of proteins. These proteins, which are
interleukins 17A and 17F, are important factors in autoimmune diseases,
including rheumatoid arthritis and psoriasis.
MSB0010841 is experimental, which means that it is not approved yet by the
Health Authorities to use as a prescribed drug in clinical practice. This is
the first time that this compound is being given to humans.
Study objective
The purpose of this research study is to investigate how safe the compound is
and how well the compound is tolerated. The study will also investigate how
quickly and to what extent the compound is absorbed and eliminated from the
body (this is called pharmacokinetics). In addition, the effect of the compound
on the body will be investigated by the evaluation of different biological
markers in the blood, in particular interleukin 17A and 17F blood levels (this
is called pharmacodynamics).
Study design
Single-center, randomized, double-blind, placebo-controlled, single ascending
dose (SAD), first-in-man (FIM) trial in healthy male subjects.
Intervention
Single doses of MSB0010841 will be administered by subcutaneous injection(s) at
the following planned dosages:
Cohort 1: 3 mg;
Cohort 2: 12 mg;
Cohort 3: 60 mg;
Cohort 4: 120 mg;
Cohort 5: 240 mg;
Cohort 6: 360 mg
Study burden and risks
- possible side-effect as described under E9
- venapunctures
- subcutaneous injections
- screening and follow-up visit
- admission to the clinic
- study activities: physical examinations, spirometry, vital signs, ECG,
holter, telemetry, local tolerability assessment
Frankfurter Str. 250
Darmstadt 64293
DE
Frankfurter Str. 250
Darmstadt 64293
DE
Listed location countries
Age
Inclusion criteria
healthy male subjects,
18 - 45 yrs, inclusive,
20.0 - 30.0 kg/m2, inclusive
Exclusion criteria
Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 90 days before the start of this study or being a blood donor within 60 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 | EUCTR2012-005064-96-NL |
| CCMO | NL43144.056.13 |