NCT07150962

Relative Bioavailability of First vs Second-Generation Formulations of HRS9531 Tablets in Obese or Overweight Subjects

A Phase I Clinical Study Comparing the Relative Bioavailability, Safety and Tolerability of the First-generation and Second-generation Formulations of HRS9531 Tablets and Exploring the Safety, Tolerability and Pharmacokinetic Characteristics of Single-dose Escalation of the Second-generation Formulation

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 168 (estimated)
• Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

This study aims to compare the relative bioavailability, safety and tolerability of the first-generation and second-generation formulations of HRS9531 tablets, as well as to explore the safety, tolerability and pharmacokinetic characteristics of the second-generation formulation in terms of single-dose escalation.

Conditions

• Overweight or Obesity

Interventions

Type	Name	Description
DRUG	HRS-9531 Tablet	HRS-9531 tablet.

Timeline

• Start date: 2025-10-15
• Primary completion: 2026-02-01
• Completion: 2026-09-01
• First posted: 2025-09-02
• Last updated: 2025-11-17

Locations

1 site across 1 country: China