drugset / Trial / NCT05690204

Dose Finding Study to Evaluate Safety and Efficacy of 3 Dosages of SAP 001.

NCT05690204 ↗

Phase 2 Active not recruiting 87 enrolled Shanton Pharma Pte. Ltd.
RandomizedParallel-groupTriple-blindTreatment

Summary

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.

Timeline

Start
2022-12-12
Primary completion
2025-01
Completion
2025-02

Drugs

EvaluationDrugModalityDoseRoute
Subject SAP-001 Unknown — Oral

Indications