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Dose Finding Study to Evaluate Safety and Efficacy of 3 Dosages of SAP 001.

NCT05690204 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 87

Last updated 2024-11-14

No results posted yet for this study

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.

Conditions

Interventions

DRUG

SAP-001

Test the efficacy and safety of SAP-001 versus placebo

Sponsors & Collaborators

  • Shanton Pharma Pte. Ltd.

    lead INDUSTRY

Principal Investigators

  • Carmen Arencibia · Study Official

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-12
Primary Completion
2025-01-31
Completion
2025-02-28
FDA Drug
Yes

Countries

  • United States
  • Puerto Rico

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05690204 on ClinicalTrials.gov