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Placebo Controlled, Dose Escalation Study to Evaluate Safety, Pharmacokinetics & Efficacy of SAP-001 in Gout Patients

NCT03857165 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2021-10-14

No results posted yet for this study

Summary

This is a Phase I, Multicenter, Randomized, Double-blind, Placebo controlled, Dose-escalation study to evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of SAP-001 in Gout Patients with Hyperuricemia. The study will be single dose ascending cohorts across three doses with a placebo control arm.

Conditions

  • Gout, Hyperuricemia

Interventions

DRUG

SAP-001

SAP-001 or placebo treatment in a 3:1 randomization ratio.

Sponsors & Collaborators

  • Shanton Pharma Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • John M Hill, MD · Accel Research Sites (Avail Clinical Research)

  • Melanie Fein · High Point Clinical Trials Center

  • Peter Winkle · Anaheim Clinical Trials, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2018-09-24
Primary Completion
2019-06-02
Completion
2019-10-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT03857165 on ClinicalTrials.gov