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This is a randomized, double-blind, placebo-controlled, single-dose, dose escalation study in healthy male and or female subjects and subjects with Rheumatoid Arthritis (RA) to determine the safety and tolerability of MORAb-022.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Escalating doses of MORAb-022 | Experimental | Subjects with RA will be randomized into Cohorts 8 to 11, with each cohort consisting of five RA subjects per cohort (four active and one placebo). |
|
| Placebo | Placebo Comparator | Subjects with RA will be also randomized into Cohorts 8 to 11, with each cohort consisting of five RA subjects per cohort (four active and one placebo). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MORAb-022 | Drug | IV infusion of MORAb-022 at increasing doses starting with the minimal anticipated biological effect level (MABEL) which is 0.0085mg/kg.; IV infusion of Placebo (saline) |
| Measure | Description | Time Frame |
|---|---|---|
| Safety to measures to include adverse events, clinical laboratory results, vital signs, ECGs, physical examinations, local tolerability at the infusion site single escalating intravenous (IV) doses of MORAb-022 in healthy subjects and subjects with RA. | Approximately 113 days |
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Inclusion Criteria for Rheumatoid Arthritis (RA) Subjects:
Exclusion Criteria for Rheumatoid Arthritis (RA)Subjects:
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| Name | Affiliation | Role |
|---|---|---|
| Alan J. Kivitz, MD, CPI | Altoona Center for Clinical Research | Principal Investigator |
| Lydie Hazan, MD | Axis Clinical Trials | Principal Investigator |
| Chrysoula Pappa, MD | Seaview Jacksonville, LLC | Principal Investigator |
| William M Schnitz, MD | Lynn Health Science Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Axis Clinical Trials | Los Angeles | California | 90036 | United States | ||
| Seaview Jacksonville, LLC |
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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 |
|---|---|
| C000711670 | gimsilumab |
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| MORAb-022 | Drug | IV infusion of MORAb-022 at increasing doses starting with the minimal anticipated biological effect level (MABEL) which is 0.0085mg/kg.; IV infusion of Placebo (saline) |
|
| Jacksonville |
| Florida |
| 32256 |
| United States |
| Lynn Health Science Institute | Oklahoma City | Oklahoma | 73112 | United States |
| Altoona Center for Clinical Research | Duncansville | Pennsylvania | 16635 | United States |
| Pharmaceutical Research Associates Group B.V. | Zuidlaren | Netherlands |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |