RecruitingPhase 1NCT07519109

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


Sponsor

CSPC Ouyi Pharmaceutical Co., Ltd.

Enrollment

60 participants

Start Date

Mar 30, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called 0.9 % sodium chloride, a drug called Ropivacaine hydrochloride, and others for people with postoperative pain. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSYH9089 injection

Before the surgical incision was closed, SYH9089 injection was applied to the incision wound.

DRUGRopivacaine hydrochloride

Before the surgical incision was closed, 0.5% ropivacaine hydrochloride was injected into the incision wound.

DRUG0.9 % sodium chloride

Before the surgical incision was closed, the incision wound was infiltrated with 0.9% sodium chloride injection.


Locations(1)

The Third Xiangya Hospital of Central South University

Changsha, Hunan, China

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NCT07519109


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