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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-005493-21 | EudraCT Number |
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The overall aims of the study are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ALX-0061 low dose i.v. | Experimental |
| |
| ALX-0061 high dose i.v. | Experimental |
| |
| ALX-0061 low dose s.c. | Experimental |
| |
| ALX-0061 middle dose s.c. | Experimental |
| |
| ALX-0061 high dose s.c. | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALX-0061 | Biological | single dose, intravenous |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: serum concentration of ALX-0061 after single subcutaneous (s.c.) and single intravenous (i.v.) doses of ALX-0061 in healthy volunteers | Day 1 to Day 32 +/- 2 days after dosing for low dose treatment arms, Day 1 to Day 46 +/-2 days after dosing for middle dose treatment arm, Day 1 to Day 53 +/- 2 days after dosing for high dose treatment arms |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacodynamics: concentration in plasma of total soluble Interleukin-6 receptor (sIL-6R) and in serum of IL-6 | During screening untill final visit (i.e. 60 +/- 2 days after dosing for the low dose and middle dose treatment arms and 83 +/- 2 days after dosing for the high dose treatment arms) | |
| Safety and tolerability: safety markers |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven De Bruyn, MD | Ablynx NV | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zuidlaren | 9470 | Netherlands |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| C000606096 | ALX-0061 |
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| ALX-0061 | Biological | single dose, subcutaneous |
|
|
| From signing of informed consent until final visit (i.e. 60 +/- 2 days for the low dose and middle dose treatment arms and 83 +/- 2 days for the high dose treatment arms |
| Immunogenicity: concentration of Anti-Drug Antibodies (ADA) in serum | From screening until final visit (i.e. 60+/- 2 days after dosing for the low dose and middle dose treatment arms and 83 +/- 2 days after dosing for the high dose treatment arms |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |