MedTrace Logo

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

NCT07519109 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-04-09

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • CSPC Ouyi Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-31
Primary Completion
2026-12-31
Completion
2027-03-31

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07519109 on ClinicalTrials.gov