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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-019234-28 | EudraCT Number | ||
| U1111-1120-2542 | Other Identifier | WHO |
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This trial is conducted in Europe. The aim of this dose-escalating trial is to assess the safety, tolerability, pharmacokinetics (the rate at which the body eliminates the trial drug) and pharmacodynamics (the effect of the investigated drug on the body) of single and repeated doses of NNC141-0100 in subjects with Rheumatoid Arthritis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single-dose (SD) trial part (i.v.) | Experimental |
| |
| Single-dose (SD) trial part (s.c.) | Experimental |
| |
| Multiple-dose (MD) trial part (s.c.) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC 0141-0000-0100 | Drug | Single dose administered subcutaneously (under the skin), up to six dose levels. Progression to next dose will be based on safety evaluation. Initiation of the MD s.c. phase will depend on the results from the SD i.v. cohorts as well as the first two dose cohorts of the SD s.c. part |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | from trial product administration to week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Antibodies against NNC141-0100 | from trial product administration until final visit (week 12 or longer if applicable) | |
| Area under the serum concentration-time curve - SD trial part | from trial product administration until final visit (week 12 or longer if applicable) |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Renaud Buffet | Innate Pharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Berlin | 13353 | Germany |
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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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|
| placebo | Drug | Single dose administered subcutaneously (under the skin) as a comparator at all dose levels |
|
| NNC 0141-0000-0100 | Drug | Multiple doses administered subcutaneously (under the skin) at 4 different occasions with a dosing interval of two weeks, at five different dose levels. |
|
| placebo | Drug | Multiple doses administered subcutaneously (under the skin) as a comparator at all dose levels |
|
| NNC 0141-0000-0100 | Drug | Single dose administered intravenously (into a vein), up to nine dose levels. Progression to next dose will be based on safety evaluation. Initiation of the SD s.c. phase will depend on the results from the first three dose cohorts of the SD i.v. part |
|
| placebo | Drug | Single dose administered intravenously (into a vein), as a comparator at all dose levels |
|
| Terminal half-life (t½) - SD trial part | from trial product administration until final visit (week 12 or longer if applicable) |
| Terminal half-life (t½) - MD trial part | from trial product administration until final visit (week 12 or longer if applicable) |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |