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

Anaheim, CA
Phase 2
Waitlist Available
Research Sponsored by Shanton Pharma Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days
Awards & highlights
No Placebo-Only Group

Summary

This trial will test a new drug to treat gout and measure its safety, how well it is tolerated, how it is processed by the body, and how it affects gout symptoms.

See full description
Eligible Conditions
  • Gout
  • Hyperuricemia
  • High Uric Acid

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
AUC0-24h
AUC0-t
AUC0-∞
+9 more
Secondary study objectives
Interleukin-1
Urate Lowering Effect

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Group I: Dose D (allopurinol patients)Experimental Treatment1 Intervention
Dose D SAP-001 versus placebo in gout patients who remain on allopurinol
Group II: Dose CExperimental Treatment1 Intervention
Dose C SAP-001 versus placebo
Group III: Dose BExperimental Treatment1 Intervention
Dose B SAP-001 versus placebo
Group IV: Dose AExperimental Treatment1 Intervention
Dose A SAP-001 versus placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SAP-001
2023
Completed Phase 2
~140

Find a Location

Closest Location:Anaheim Clinical Trials (ACT)· Anaheim, CA

Who is running the clinical trial?

Shanton Pharma Co., Ltd.Lead Sponsor
3 Previous Clinical Trials
181 Total Patients Enrolled
3 Trials studying Gout
181 Patients Enrolled for Gout
Celina Cabale-Scholl, DPT, RNStudy ChairShanton Pharma
~6 spots leftby Mar 2026
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