Clinical Trials Logo
  1. Home
  2. Gout
  3. NCT04040816

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

Gout Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04040816
Study type Interventional
Source Shanton Pharma Co., Ltd.
Contact
Status Completed
Phase Phase 2
Start date January 1, 2019
Completion date August 30, 2020
View Details
See also
  Status Clinical Trial Phase
Completed NCT04060173 - A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ABP-671 Phase 1
Not yet recruiting NCT06187519 - UR+AIMS Gout Wearable Skin Uric Acid Monitor Study N/A
Completed NCT03635957 - Study of Pegloticase (KRYSTEXXA®) Plus Methotrexate in Patients With Uncontrolled Gout Phase 4
Completed NCT04966325 - Thorough QT (TQT) Study to Evaluate the Effect of LC350189 on Cardiac Repolarization in Healthy Male and Female Subjects Early Phase 1
Completed NCT03015948 - A Single Dose Study of SHR4640 in Healthy Male Volunteers Phase 1
Completed NCT02855437 - Novel Methods for Ascertainment of Gout Flares -A Pilot Study N/A
Active, not recruiting NCT02702375 - Meta-analyses of Impotrant Food Sources of Sugars and Incident Cardiometabolic Diseases N/A
Completed NCT01407874 - A Randomized, Double-Blind, Dose-Response Study of the Safety and Uric Acid Effects of Oral Ulodesine Added to Allopurinol in Subjects With Gout and Concomitant Moderate Renal Insufficiency Phase 2
Completed NCT00995618 - Study of Tranilast Alone or in Combination With Febuxostat in Patients With Hyperuricemia Phase 2
Completed NCT00985127 - Study to Evaluate the Urate-Lowering Activity and Safety of Oral BCX4208 Administered in Subjects With Gout Phase 2
Terminated NCT04987294 - Phase IIa Study of ALLN-346 (Engineered Urate Oxidase) in Subjects With Hyperuricemia, Gout and Chronic Kidney Disease Phase 2
Completed NCT03291782 - D-0120 Safety and PK/PD, Food Effect Study in Healthy Volunteers Phase 1
Recruiting NCT03388515 - A Study to Assess the Safety and Tolerability of SSS11 in Healthy Subjects. Phase 1
Completed NCT06189404 - Effect of Tigulixostat on the Pharmacokinetics of Theophylline Phase 1
Enrolling by invitation NCT03336203 - The Impact of Urate-lowering Therapy on Kidney Function (IMPULsKF) Phase 4
Recruiting NCT05586958 - Tigulixostat, Phase 3 Study, Placebo Controlled in Gout Patients Phase 3
Recruiting NCT04047394 - A Study to Determine the Safety, Tolerability, PK and Preliminary PD of SSS11 in Chinese Healthy Adult Volunteers Phase 1
Not yet recruiting NCT05507723 - Tight Control of Gouty Arthritis Compared to Usual Care N/A
Recruiting NCT06056570 - Open Label PK, PD and DDI of Dotinurad and Allopurinol in Gout Patients With Hyperuricemia Phase 1/Phase 2
Completed NCT02557126 - Study of URC102 to Assess the Safety and Efficacy in Gout Patients Phase 2