NCT07519109

Study Evaluating the Safety, Efficacy and Pharmacokinetics of SYH9089 Injection in Patients Undergoing Abdominal Surgery.

A Multicenter, Randomized, Double-Blind, Active Drug and Placebo Parallel-Controlled, Dose-Escalation Phase I Study to Evaluate the Safety , Pharmacokinetics, and Efficacy of SYH9089 Injection in Patients Undergoing Abdominal Surgery

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: CSPC Ouyi Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, double-blind, active drug- and placebo-controlled, dose-escalation clinical study conducted in patients scheduled to undergo abdominal surgery. It aims to evaluate the tolerability, safety, pharmacokinetics, and efficacy of SYH9089 Injection for postoperative analgesia in these patients.

Conditions

• Postoperative Pain

Interventions

Type	Name	Description
DRUG	SYH9089 injection	Before the surgical incision was closed, SYH9089 injection was applied to the incision wound.
DRUG	Ropivacaine hydrochloride	Before the surgical incision was closed, 0.5% ropivacaine hydrochloride was injected into the incision wound, and a total of 20mL was given.
DRUG	0.9 % sodium chloride	Before the surgical incision was closed, the incision wound was infiltrated with 0.9% sodium chloride injection.

Timeline

• Start date: 2026-03-31
• Primary completion: 2026-12-31
• Completion: 2027-03-31
• First posted: 2026-04-09
• Last updated: 2026-04-09