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NOT YET RECRUITING
NCT07519109
PHASE1

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

Sponsor: CSPC Ouyi Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2026-03-31

Completion Date

2027-03-31

Last Updated

2026-04-09

Healthy Volunteers

No

Interventions

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.