NCT06792955

The Evaluation of Bioequivalence Between a Single-dose Pen and a Multi-dose Pen of HRS9531 Injection Solution

A Single-center, Single-dose, Randomized, Open-label, Single-period, Parallel Bioequivalence Study of HRS9531 Injection Solution in Multi-dose Pens and Single-dose Pens in Overweight/Obese Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

The study is being conducted to evaluate the bioequivalence between a single-dose pen and a multi-dose pen of HRS9531 injection solution.

Conditions

• Overweight/Obesity

Interventions

Type	Name	Description
DRUG	HRS9531 injection	Multi-dose pen of HRS9531 injection solution.
DRUG	HRS9531 injection	Single-dose pen of HRS9531 injection solution.

Timeline

• Start date: 2025-02-11
• Primary completion: 2025-06-06
• Completion: 2025-06-06
• First posted: 2025-01-27
• Last updated: 2025-06-12

Locations

1 site across 1 country: China