drugset / Trial / NCT03890302

Evaluate the Safety, Tolerability, Pharmacokinetics,and Clinical Activity of FB704A

NCT03890302 ↗

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

EvaluationDrugModalityDoseRoute
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

Indications