NCT03857165

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

A 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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Shanton Pharma Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

A total of 24 eligible adult subjects will be randomized in a 3:1 randomization ratio into two blinded treatment groups in the three dose cohorts with matching placebo arm. The duration of the observation would be 5 days for each subject with a single SAP-001 dosing to evaluate safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and efficacy of oral SAP-001 (once daily) in adults gout patients with hyperuricemia.

Conditions

• Gout, Hyperuricemia

Interventions

Type	Name	Description
DRUG	SAP-001	SAP-001 or placebo treatment in a 3:1 randomization ratio.

Timeline

• Start date: 2018-09-24
• Primary completion: 2019-06-02
• Completion: 2019-10-31
• First posted: 2019-02-27
• Last updated: 2021-10-14

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study