Ignite Creation Date:
2024-05-06 @ 6:31 PM
Last Modification Date:
2024-10-26 @ 2:49 PM
Study NCT ID:
NCT05690204
Status:
COMPLETED
Last Update Posted:
2024-02-09
First Post:
2022-12-12
Brief Title:
Dose Finding Study to Evaluate Safety and Efficacy of 3 Dosages of SAP 001
Sponsor:
Shanton Pharma Co Ltd
Organization:
Shanton Pharma Co Ltd
Study Overview
Official Title:
A Phase 2B Double-blind Placebo-controlled Dose-finding Study to Evaluate the Efficacy and Safety of 3 Dosages of SAP-001 in Combination With Standard of Care in Adult Subjects With Gout
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this study is to confirm the safety and pharmacological characteristics of SAP-001 evaluate its efficacy in lowering sUA and tophus burden and identify the appropriate dose regimen for future studies in adult subjects with gout with or without tophi and hyperuricemia refractory to SoC XOI therapy
Detailed Description:
A Phase 2B multicenter randomized double-blind placebo-controlled dose-finding study to assess the safety PK PD and efficacy of 3 orally administered dosages of SAP-001 10 mg QD 30 mg QD and 60 mg QD compared to placebo QD in adult subjects with gout with or without tophi and hyperuricemia refractory to standard-of-care SoC XOI therapy In the completed Phase 1 and Phase 2 studies SAP-001 was well tolerated at single doses up to 120 mg and at dosages up to 60 mg QD for 28-days in subjects with gout and hyperuricemia and demonstrated statistically significant reductions in sUA levels compared to placebo
The aim of this study is to confirm the safety and pharmacological characteristics of SAP-001
The aim of this study is to confirm the safety and pharmacological characteristics of SAP-001
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None