Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Oneness Biotech Co., Ltd. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
The cause of Rheumatoid Arthritis (RA) is not fully understood. However, one of the substances secreted by certain cells in the body, interleukin-6 (IL-6), is believed to play a major role in chronic inflammation that is typical in RA. This study investigates the drug FB704A, which is believed to lower the inflammation caused by IL-6. This study will be in 2 sequential parts: a single increasing dose part (Part 1) and a multiple-increasing dose part (Part 2). Subjects will receive either active or placebo drug by IV infusion. Subjects in both parts will have a short stay in the clinic at the start of the study, then will return for outpatient visits.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A | Experimental | 0.5 mg/kg study drug, or placebo, administered once |
|
| Cohort B | Experimental | 2 mg/kg study drug, or placebo, administered once |
|
| Cohort C | Experimental | 4 mg/kg study drug, or placebo, administered once |
|
| Cohort D | Experimental | 8 mg/kg study drug, or placebo, administered once |
|
| Cohort E | Experimental | Starting dose of 2 mg/kg or approximately half the maximum tolerated dose (MTD) in Part 1 (Cohorts A-D), whichever is lower, up to 4 mg/kg; or placebo. Administered 4 times (approximately once every 2 weeks). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FB704A | Drug | Administered by IV infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events (AEs) (Part 1) | Up to Day 57 | |
| Incidence of Adverse Events (AEs) (Part 2) | Up to Day 99 | |
| Number of participants with clinical laboratory abnormalities (Part 1) | Up to Day 57 | |
| Number of participants with clinical laboratory abnormalities (Part 1) | Up to Day 99 | |
| Number of participants with physical examination abnormalities (Part 1) | Up to Day 57 | |
| Number of participants with physical examination abnormalities (Part 2) | Up to Day 99 | |
| Number of participants with dose limiting toxicities (DLT) (Part 1) | Up to Day 57 | |
| Number of participants with dose limiting toxicities (DLT) (Part 2) | Up to Day 99 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria could apply.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Martin Kankam, MD | Altasciences Company Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Altasciences Clinical Kansas, Inc. | Overland Park | Kansas | 66212 | United States |
Not provided
| Label | URL |
|---|---|
| FDA Safety Alerts and Recalls | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Identical in appearance and same excipients as FB704A, but without active compound. Administered by IV infusion |
|
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |