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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-018347-33 | EudraCT Number | ||
| U1111-1116-2585 | Other Identifier | WHO |
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This trial is conducted in Europe. The aim of this trial is to investigate the safety, tolerability, pharmacokinetic (the effect of the body on the investigated drug), pharmacodynamic biomarkers (biomarkers related to anti-IL-21 expected mode of action) and signs of clinical efficacy of increasing single doses, at 9 i.v. (into the vein) dose levels in Healthy Subjects , at 3 i.v. dose levels in subjects with rheumatoid arthritis (RA) and at 3 s.c. dose levels in Healthy Subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose level 1 | Experimental |
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| Dose level 2 | Experimental |
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| Dose level 3 | Experimental |
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| Dose level 4 | Experimental |
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| Dose level 5 | Experimental |
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| Dose level 6 | Experimental |
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| Dose level 7 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC0114-0000-0005 | Drug | A single dose of NNC0114-0000-0005 administered i.v. (into the vein) in healthy subjects. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | at least 12 weeks after dose administration |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the serum concentration-time curve | at least 12 weeks after dose administration | |
| Maximum level of free IL-21 and maximum level of bound IL-21 in peripheral blood | at least 12 weeks after dose administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Berlin | 10117 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | First in human study with recombinant anti-IL-21 monoclonal antibody in healthy subjects and patients with rheumatoid arthritis. Arthritis and Rheumatism 2012; 64 (10 (supplement)): Abstract 1279 |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
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| Dose level 8 | Experimental |
|
| NNC0114-0000-0005 | Drug | A single dose of NNC0114-0000-0005 administered i.v. (into the vein) in healthy subjects. Based on safety data, a single dose of NNC0114-0000-0005 may be administered i.v. (into the vein) in subjects with RA. In addition a single dose of NNC0114-0000-0005 administered s.c. (under the skin) in healthy subjects. |
|
| NNC0114-0000-0005 | Drug | A single dose of NNC0114-0000-0005 administered i.v. (into the vein) in healthy subjects. In addition a single dose of NNC0114-0000-0005 may be administered s.c. (under the skin) in healthy subjects based on safety data. |
|
| NNC0114-0000-0005 | Drug | A single dose of NNC0114-0000-0005 administered i.v. (into the vein) in healthy subjects. Based on safety data, a single dose of NNC0114-0000-0005 may be administered i.v. (into the vein) in subjects with RA. In addition a single dose of NNC0114-0000-0005 may be administered s.c. (under the skin) in healthy subjects based on safety data. |
|
| NNC0114-0000-0005 | Drug | A single dose of NNC0114-0000-0005 administered i.v. (into the vein) in healthy subjects. Based on safety data, a single dose of NNC0114-0000-0005 may be administered i.v. (into the vein) in subjects with RA. |
|
| placebo | Drug | A single dose of NNC0114-0000-0005 placebo. |
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| Change in Disease Activity Score 28 (DAS28)-C-reactive protein (CRP) in subjects with RA | at least 12 weeks after dose administration |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |