A Phase 1 interventional study of FB704A and Placebo in Rheumatoid Arthritis, sponsored by Fountain Biopharma Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-07-21.
Sponsored by Fountain Biopharma Inc. · Phase 1, Interventional, and Treatment
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.
3,554 studies on the registry are indexed under Arthritis; 318 are open to participants now.
This study's enrollment of 31 is below the median of 90 across 2,377 interventional studies indexed under Arthritis.
Browse Arthritis studies →Fountain Biopharma Inc. is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria could apply.
0.5 mg/kg study drug, or placebo, administered once
Drug: FB704A · Drug: Placebo
2 mg/kg study drug, or placebo, administered once
Drug: FB704A · Drug: Placebo
4 mg/kg study drug, or placebo, administered once
Drug: FB704A · Drug: Placebo
8 mg/kg study drug, or placebo, administered once
Drug: FB704A · Drug: Placebo
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).
Drug: FB704A · Drug: Placebo
Administered by IV infusion
Identical in appearance and same excipients as FB704A, but without active compound. Administered by IV infusion
Incidence of Adverse Events (AEs) (Part 1)
Time frame: Up to Day 57
Incidence of Adverse Events (AEs) (Part 2)
Time frame: Up to Day 99
Number of participants with clinical laboratory abnormalities (Part 1)
Time frame: Up to Day 57
Number of participants with clinical laboratory abnormalities (Part 1)
Time frame: Up to Day 99
Number of participants with physical examination abnormalities (Part 1)
Time frame: Up to Day 57
Number of participants with physical examination abnormalities (Part 2)
Time frame: Up to Day 99
Number of participants with dose limiting toxicities (DLT) (Part 1)
Time frame: Up to Day 57
Number of participants with dose limiting toxicities (DLT) (Part 2)
Time frame: Up to Day 99
Plan to share: No
This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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Fountain Biopharma Inc.