drugset / Trial / NCT04040816

Placebo Controlled, Multiple Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SAP-001 in Gout Patients

NCT04040816 ↗

Phase 2 Completed 40 enrolled Shanton Pharma Co., Ltd.
RandomizedSequentialDouble-blindTreatment

Summary

This is a Phase II, Multicenter, Randomized, Double-blind, Placebo controlled, Multiple Dose study to evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SAP-001 in Gout Patients with Hyperuricemia.

Timeline

Start
2019-01-01
Primary completion
2020-08-01
Completion
2020-08-30

Outcome

Met primary endpoint

release “The Shanton Pharma Phase 2 study evaluating its investigational product SAP-001, an oral, small molecule, achieved its primary endpoint.” shantonpharma.com ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject SAP-001 Unknown — —

Indications