NCT06678581

SAD,MAD and Food Effect Study of SAP-001 Tablets in Chinese Subjects

A Randomized, Double-Blind, Placebo-Controlled, Single or Multiple Dose Escalation Study to Evaluate the Safety, PK Profile, PD Profile and Food Effects of SAP-001 Tablets in Healthy Chinese Subjects and Gout Patients With Hyperuricemia

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Shanton Pharma Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

To evaluate the pharmacokinetics (PK) profile of single or multiple oral doses of SAP-001 tablets in healthy Chinese subjects and gout patients with hyperuricemia. To evaluate the safety and tolerability of single oral doses of SAP-001 tablets in healthy Chinese subjects and multiple oral doses of SAP-001 tablets in gout patients with hyperuricemia. To evaluate the pharmacodynamics (PD) profile of single oral doses of SAP-001 tablets in healthy Chinese subjects and multiple oral doses of SAP-001 tablets in gout patients with hyperuricemia. To evaluate the pharmacokinetics profile of SAP-001 tablets in healthy Chinese subjects under fasted/fed conditions.

Conditions

• Gout
• Hyperuricemia

Interventions

Type	Name	Description
DRUG	SAP-001	Solid Oral Tablet
DRUG	Placebo	Solid Oral Tablet

Timeline

• Start date: 2023-05-29
• Primary completion: 2023-12-20
• Completion: 2024-01-11
• First posted: 2024-11-07
• Last updated: 2024-11-12

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study