drugset / Trial / NCT03890302
Evaluate the Safety, Tolerability, Pharmacokinetics,and Clinical Activity of FB704A
RandomizedSequentialDouble-blindTreatment
Summary
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.
Timeline
- Start
- 2019-03-14
- Primary completion
- 2020-05-27
- Completion
- 2020-05-27
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | FB704A | Monoclonal antibody | 0.5 mg/kg | Intravenous |
| Subject | FB704A | Monoclonal antibody | 2 mg/kg | Intravenous |
| Subject | FB704A | Monoclonal antibody | 4 mg/kg | Intravenous |
| Subject | FB704A | Monoclonal antibody | 8 mg/kg | Intravenous |