NCT04040816

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Shanton Pharma Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This multiple dose study will include up to 4 cohorts. Each cohort will be comprised of 15 patients who will be dosed with SAP-001 or placebo once daily (QD) for 28 days. Dose escalation from Cohort 1 to Cohort 2 will occur after preliminary data are partially unblinded and safety data along with PK and PD parameters are analyzed and reviewed. Enrollment in Cohort 3 will begin after the last subject is randomized into Cohort 2. Prior to starting enrollment into Cohort 4, a complete safety assessment of Cohorts 1, 2 and 3 will be performed to select the dose to be used in Cohort 4.

Conditions

• Gout
• Hyperuricemia

Interventions

Type	Name	Description
DRUG	SAP-001	SAP-001 or placebo treatment in a 4:1 randomization ratio

Timeline

• Start date: 2019-01-01
• Primary completion: 2020-08-01
• Completion: 2020-08-30
• First posted: 2019-08-01
• Last updated: 2021-11-05

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study