drugset / Trial / NCT03857165

Placebo Controlled, Dose Escalation Study to Evaluate Safety, Pharmacokinetics & Efficacy of SAP-001 in Gout Patients

NCT03857165 ↗

Phase 1 Completed 24 enrolled Shanton Pharma Co., Ltd.
RandomizedSequentialQuadruple-blindTreatment

Summary

This is a Phase I, Multicenter, Randomized, Double-blind, Placebo controlled, Dose-escalation study to evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of SAP-001 in Gout Patients with Hyperuricemia. The study will be single dose ascending cohorts across three doses with a placebo control arm.

Timeline

Start
2018-09-24
Primary completion
2019-06-02
Completion
2019-10-31

Drugs

EvaluationDrugModalityDoseRoute
Subject SAP-001 Unknown — Oral

Indications