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

NCT06678581 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2024-11-12

No results posted yet for this study

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

DRUG

SAP-001

Solid Oral Tablet

DRUG

Placebo

Solid Oral Tablet

Sponsors & Collaborators

  • Shanton Pharma Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Li Li · Shanton Pharma Co., Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-05-29
Primary Completion
2023-12-20
Completion
2024-01-11
FDA Drug
Yes

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT06678581 on ClinicalTrials.gov