This study is to assess the safety, tolerability, and pharmacokinetics (PK) of multiple infusions of GS-5745 in adults with rheumatoid arthritis (RA). Participants will be randomized in a 4:1 ratio to receive 1 intravenous (IV) infusion of GS-5745 or placebo every 2 weeks, for a total of 3 IV infusions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
18
GS-5745 400 mg administered intravenously
Placebo to match GS-5745 administered intravenously
Unnamed facility
Prague, Czechia
Unnamed facility
Balatonfüred, Veszprém megye, Hungary
Unnamed facility
Budapest, Hungary
Unnamed facility
Debrecen, Hungary
Incidence of adverse events, changes in laboratory tests and vital signs from baseline, and development of immunogenicity after dosing
This composite endpoint will measure the safety and tolerability profile of GS-5745.
Time frame: Up to 100 days
PK profile of GS-5745
This composite endpoint will measure the plasma PK profile of GS-5745. The following parameters will be measured, where applicable: * Cmax: maximum observed concentration of drug in plasma * Tmax: time of Cmax * Clast: last observable concentration of drug * Tlast: time of Clast * AUClast: concentration of drug from time zero to the last quantifiable concentration * AUCinf: concentration of drug extrapolated to infinite time (area under the plasma concentration versus time curve extrapolated to infinite time) * AUCtau: concentration of drug over time (area under the plasma concentration versus time curve over the dosing interval) * Ctau: observed drug concentration at the end of the dosing interval * λz: terminal elimination rate constant * CL: systemic clearance of the drug following intravenous administration * Vz: volume of distribution of the drug following intravenous administration
Time frame: Pre-infusion, 30 minutes, 4 hours, and 24 hours post-infusion on Day 1; pre-infusion and 30 minutes post-infusion on Days 15 and 29; Days 4, 8, 36, and 43
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