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This will be a Phase II, multi-centre study consisting of 2 parts. Part 1: Clinical Pharmacology Study (drug-drug interaction between AK106-001616 and methotrexate) Part 2: Proof of Concept Study
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AK106-001616 | Experimental |
| |
| Placebo | Placebo Comparator | Part1: AK106-001616 and Placebo |
|
| Active comparator | Active Comparator | Part2: AK106-001616 and Active comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AK106-001616 | Drug | Part1: Dose escalation Part2: Dose expansion |
| |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hlučín | Czechia | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25579091 | Derived | Kozaki T, Tagashira M, Yamanishi K, Ellis B, Kayanoki T, Ooishi R, Sugiyama K, Matsuda S, Tsuruta K, Kohira T, Tsurui K. Evaluation of drug-drug interaction between the novel cPLA2 inhibitor AK106-001616 and methotrexate in rheumatoid arthritis patients. Xenobiotica. 2015;45(7):615-24. doi: 10.3109/00498254.2014.1000430. Epub 2015 Jan 12. |
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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 |
|---|---|
| C000656266 | AK106-001616 |
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| Placebo |
| Drug |
|
| Active comparator | Drug |
|
| Prague |
| Czechia |
| Uherské Hradiště | Czechia |
| Frankfurt am Main | Hesse | Germany |
| Berlin | Germany |
| Hamburg | Germany |
| Budapest | Hungary |
| Érd | Hungary |
| Vilnius | Lithuania |
| Bucharest | Romania |
| Cambridge | Cambridgeshire | United Kingdom |
| Sheffield | South Yorkshire | United Kingdom |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |