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

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.

Timeline

Start

2023-05-29

Primary completion

2023-12-20

Completion

2024-01-11

Drugs

Indications