A Phase 1b, Randomized, Blinded, Placebo-Controlled, Multicenter Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of GS-0151 in Adult Participants With Rheumatoid Arthritis
Gilead Sciences
Summary
The goal of this clinical study is to learn more about the study drug GS-0151. The study is done to find how safe, well-tolerated the drug is. This will also assess how the drug is absorbed, modified, distributed and cleared from the body (the pharmacokinetics (PK) of the drug), when given multiple times to participants with rheumatoid arthritis (RA). The primary objectives of this study is to assess the safety and tolerability of multiple ascending doses of GS-0151 in participants with RA and to characterize the PK of GS-0151 following multiple doses of GS-0151 in participants with RA.
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
Key Inclusion Criteria: Medical History/Physical Characteristics; All Cohorts: * Individuals must not be on a biologic disease-modifying antirheumatic drug (b/tsDMARD) on Day 1 and must have discontinued all b/tsDMARDs (including biosimilars and generics) at least 4 weeks prior to Day 1 with the exception of B cell-depleting agents (eg, rituximab), which must be discontinued for at least 6 months prior to Day 1. * Ongoing treatment with at least 1 but no more than 2 protocol-permitted conventional synthetic disease-modifying antirheumatic drug (csDMARDs) for at least 12 weeks, at a stable do…
Interventions
- DrugGS-0151
Administered for 12 weeks
- DrugPlacebo
Administered for 12 weeks
Locations (32)
- Pinnacle Research Group, LLCAnniston, Alabama
- University of California, San DiegoLa Jolla, California
- Stanford University School of MedicinePalo Alto, California
- Medvin Clinical ResearchTujunga, California
- Medvin Clinical ResearchWhittier, California
- Clinical Research of West Florida, IncClearwater, Florida