Trial Summary
What is the purpose of this trial?This is a multicenter, open-label, non-randomized, parallel-group, single-dose, 2-part, adaptive study in which up to approximately 32 adult subjects will be enrolled in one of 4 groups (8 subjects per group) with varying degrees of renal function.
Eligibility Criteria
This trial is for adults with different levels of kidney function, including those with kidney failure, gout, or high uric acid levels. Up to 32 participants will be divided into 4 groups based on their kidney health.Participant Groups
The study is testing SAP-001, a new treatment, in a single-dose study across multiple centers. It's an open-label and non-randomized trial, meaning everyone knows what treatment they're getting and they're not assigned by chance.
4Treatment groups
Experimental Treatment
Group I: Severe renal impairmentExperimental Treatment1 Intervention
Subjects with severe renal impairment(Optional)
Group II: Moderate renal impairmentExperimental Treatment1 Intervention
Subjects with moderate renal impairment
Group III: Mild renal impairmentExperimental Treatment1 Intervention
Subjects with mild renal impairment
Group IV: Healthy matchExperimental Treatment1 Intervention
Matched healthy subjects with normal renal function
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Genesis Clinical ResearchTampa, FL
Nucleus Network Pty LtdSaint Paul, MN
Loading ...
Who is running the clinical trial?
Shanton Pharma Pte. Ltd.Lead Sponsor