Dose Finding Study to Evaluate Safety and Efficacy of 3 Dosages of SAP 001.
Running, not enrolling · Phase 2 · Has a placebo group
Conditions studied: Gout
In brief
The aim of this study is to confirm the safety and pharmacological characteristics of SAP-001, evaluate its efficacy in lowering sUA and tophus burden, and identify the appropriate dose regimen for future studies in adult subjects with gout, with or without tophi, and hyperuricemia refractory to SoC XOI therapy.
Key facts
- Study ID
- NCT05690204
- Run by
- Shanton Pharma Pte. Ltd.
- People needed
- 87
- Starts
- 2022-12-12
- Expected to finish
- 2025-02-01
- Last updated by the study team
- 2024-11-14
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
Where it is running
- California Site — Sacramento, California, United States
- California Site — San Diego, California, United States
- Denver Site — Denver, Colorado, United States
- Florida Site — DeBary, Florida, United States
- Florida Site — Miami, Florida, United States
- Florida Site — Miami Lakes, Florida, United States
- Florida Site — Miami Lakes, Florida, United States
- Florida Site — Winter Park, Florida, United States
- Idaho Site — Boise, Idaho, United States
- Maryland Site — Oxon Hill, Maryland, United States
- Mississippi Site — Jackson, Mississippi, United States
- North Carolina Site — Raleigh, North Carolina, United States
- Texas Site — Mesquite, Texas, United States
- Texas Site — Plano, Texas, United States
- Texas Site — The Woodlands, Texas, United States
- Puerto Rico Site — San Juan, Puerto Rico
Full record on ClinicalTrials.gov
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