The purpose of the study is to investigate to what extent ALX-0061 is tolerated. It will also be investigated how quickly and to what extent ALX-0061 is absorbed and eliminated from the body (this is called pharmacokinetics), and how much of the…
ID
Source
Brief title
Condition
- Autoimmune disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary objective:
To assess the pharmacokinetics of single subcutaneous (s.c.) and intravenous
(i.v.) doses of ALX-0061 in healthy volunteers.
Secondary outcome
Secondary objective:
To assess the pharmacodynamics, safety, tolerability, and immunogenicity of
single s.c. and i.v. doses of ALX-0061 in healthy volunteers.
Background summary
ALX-0061 is a new investigational compound that may eventually be used for the
treatment of rheumatoid arthritis and possibly other immune mediated disorders
(such as systemic lupus erythematosus). Rheumatoid arthritis is a chronic
systemic inflammatory disease (autoimmune disease), localized primarily in
joints of the hands and feet. Patients with rheumatoid arthritis often have
elevated blood levels of interleukin-6, a protein which stimulates the
inflammatory process leading to joint destruction.
ALX-0061 inhibits the inflammatory effects of interleukin-6. ALX-0061 is
protein that consists of several parts (building blocks) that are present in
the human body by nature (a so called *nanobody*). ALX-0061 is currently under
development and is not yet registered as a drug, but in a previous study it has
been given to patients with rheumatoid arthritis.
Study objective
The purpose of the study is to investigate to what extent ALX-0061 is
tolerated. It will also be investigated how quickly and to what extent ALX-0061
is absorbed and eliminated from the body (this is called pharmacokinetics), and
how much of the compound is absorbed in the body when administered
subcutaneously when compared to an intravenous administration (this is called
absolute bioavailability). In addition, the effect of ALX-0061 on the immune
response and the extent of inhibition of interleukin-6 will be investigated
(this is called pharmacodynamics). For the purpose of the study the possible
development of antibodies against ALX-0061 will be investigated in your blood.
The development of antibodies against the ALX-0061 may make the drug less
effective.
Study design
Day 1 is the day of administration of study medication. The actual study will
consist of 1 period during which the volunteers will stay in the clinical
research center in Groningen for 4 days (3 nights: from Day -1 to Day 3). They
will return for a number of ambulant visits as specified for each treatment
group below:
When they participate in Group 1 or 2 (50 mg ALX-0061), they will return for 7
ambulant visits to the clinical research center on Days 4, 6, 8, 11, 18, 25 and
32. Next, they will return for a final post study screening on Day 60.
The participation to the entire study, from pre-study screening until the post
study screening, will be maximally 90 days.
When they participate in Group 3 (150 mg ALX-0061), they will return for 9
ambulatory visits to the clinical research center on Days 4, 6, 8, 11, 18, 25,
32, 39 and 46. Next, they will return for a final post-study screening on Day
60.
The participation to the entire study, from pre-study screening until the post
study screening, will be maximally 90 days.
When they participate in Group 4 or 5 (300 mg ALX-0061) , they will return for
10 ambulatory visits to the clinical research center on Days 4, 6, 8, 11, 18,
25, 32, 39, 46 and 53. Next, they will return for a post-study screening on Day
83.
The participation to the entire study, from pre-study screening until the post
study screening, will be maximally 113 days.
Intervention
The volunteers will receive a single dose of ALX-0061 according to one of the 5
treatment groups below:
Group Day Route of administration Treatment
1 1 intravenously 50 mg ALX-0061
2 1 subcutaneously 50 mg ALX-0061
3 1 subcutaneously 150 mg ALX-0061
4 1 intravenously 300 mg ALX-0061
5 1 subcutaneously 300 mg ALX-0061
Study burden and risks
Registration of adverse effects: During the entire study all adverse effects
you report will be documented.
Blood sampling, indwelling cannula:
During this study less than 500 milliliters of blood will be drawn. The blood
samples will be drawn by direct puncture of the vein.
Heart trace (ECG): ECGs will be made regularly.
Intravenous (i.v.) administration (Group 1 or 4): For the i.v. administration
of study drug on Day 1 you will have an indwelling cannula inserted. The
cannula for the i.v. infusion will be removed immediately after dosing.
Subcutaneous injection (Group 2, 3 or 5): On Day 1 of the study you will
receive 1 or 2 injections in the skin of the abdomen
Injection Site Reaction: A nurse will examine the injection site several times
during the study by using the injection site reaction score list.
Technologiepark 21
Zwijnaarde B-9052
BE
Technologiepark 21
Zwijnaarde B-9052
BE
Listed location countries
Age
Inclusion criteria
Healthy male or female volunteers
Age between 18 and 55 years
BMI between 18.0 - 30.0 kg/m2
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 | EUCTR2013-005493-21-NL |
| CCMO | NL48280.056.14 |