A Phase 1, Open-Label, Parallel-Group, Single-Dose Adaptive Study to Evaluate the Safety and Pharmacokinetics of SAP-001 in Adult Subjects With Normal and Impaired Renal Function

Shanton Pharma Pte. Ltd.2 sites in 1 country32 target enrollmentApril 24, 2024

ConditionsGout Hyperuricemia

InterventionsSAP-001

DrugsSAP-001

Overview

Phase: Phase 1
Intervention: SAP-001
Conditions: Gout
Sponsor: Shanton Pharma Pte. Ltd.
Enrollment: 32
Locations: 2
Primary Endpoint: maximum observed concentration (Cmax)
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

April 24, 2024

End Date

April 28, 2025

Last Updated

last year

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Shanton Pharma Pte. Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•All subjects:
•Provision of signed and dated informed consent form (ICF)
•Subject is, as stated and in the opinion of the Investigator, willing and able to comply with the study drug regimen and all other protocol and study procedures and requirements, and is available for the duration of the study
•Adult male or female
•Subject is willing to comply with the contraceptive requirements as defined in APPENDIX 6
•Aged at least 18 years but not older than 80 years
•BMI ≥ 18.5 kg/m2 and \< 42.0 kg/m2 at the time of Screening.
•Light-, non- or ex-smoker (A light smoker is defined as someone using 10.0 nicotine units \[1 unit = 1 cigarette\] or less per day for at least 90 days prior to study drug administration. An ex-smoker is defined as someone who completely stopped using nicotine products for at least 180 days prior to study drug administration)
•Having suitable venous access for blood sampling
•Subjects with Normal Renal Function (Group 4):

Exclusion Criteria

•All subjects:
•Female who is lactating
•Female who is pregnant according to the pregnancy test at Screening or prior to study drug administration
•History of significant hypersensitivity to SAP-001 or any related products (including excipients of the formulation) as well as severe hypersensitivity reactions (like angioedema) to any drugs
•Positive screening results to HIV Ag/Ab Combo and Hepatitis B surface antigen (HBsAg)
•Positive reflex test for Hepatitis C antibody (positive Hepatitis C antibody is allowed if HCV RNA is not detected)
•Presence or history of any disorder that could interfere with completion of the study based on the opinion of an Investigator
•Intake of SAP-001 or any Investigational Product (IP) in the 28 days (or 5 times the half-life of the drug, whichever is longer) prior to study drug administration
•Have urinary incontinence without catheterization
•Reception of blood products within 3 months prior to study drug administration