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NCT Number: NCT07519109

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The Third Xiangya Hospital of Central South University

Changsha, Hunan, 410013, China

Location status: Recruiting

Location contact

Guoping Yang, PhD

CONTACT

[email protected]

0731-89918665

Guoping Yang, PhD

PRINCIPAL_INVESTIGATOR

Wen Ouyang, M.D.

CONTACT

[email protected]

0731-8861815

Wen Ouyang, M.D.

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 1. Fully understand the purpose and significance of this study, voluntarily participate in this study, voluntarily sign the informed consent, and voluntarily abide by the process of this study; 2. 18 years old ≤ age ≤75 years old, regardless of gender; 3. 19.0kg/m2≤BMI≤28.0kg/m2, ≥50.0kg for men and ≥45.0kg for women; 4. American Society of Anesthesiologists (ASA) grade I-II; 5. 5. Elective abdominal surgery under general anesthesia, and the length of the main incision is expected to be between 5-9cm (including the boundary value at both ends); 6. Can understand the research process and the use of various scales involved in this study, and can effectively communicate with researchers.

Exclusion criteria

  • 1. Patients with a history of hypersensitivity to the investigational drug, comparator drug, surgical anesthetics, rescue analgesic drugs, or other drugs that may be used during the trial; 2. Patients with a history of drug abuse/substance use, or those with positive results on a drug abuse screening; 3. Patients with neurological/psychiatric, respiratory, endocrine, hematologic, musculoskeletal, gastrointestinal, cardiovascular systems, or hepatic/renal diseases, judged by the investigator to be unsuitable for the trial; 4. Patients with a history of diabetes mellitus; 5. Patients with a history of myocardial infarction or unstable angina within 1 year prior to randomization; 6. Patients scheduled to undergo purely diagnostic exploratory surgery or palliative tumor resection, judged by the investigator to be unsuitable for the trial; 7. Patients with advanced malignant tumors, judged by the investigator to be unsuitable for the trial; 8. Combined with other pain conditions that may confound the evaluation of postoperative pain according to the investigator; 9. Patients with a history of severe or refractory postoperative nausea or vomiting; 10. Patients scheduled to receive interventions (e.g., intraperitoneal hyperthermic chemotherapy, local/intraperitoneal chemoperfusion, or infrared therapy) during the observation period (randomization to 120h after administration) that may interfere with postoperative pain assessment 11. Use of the following drugs for less than 5 half-lives before randomization (based on the actual drug instructions; or within 7 days prior to randomization if the half-life is unclear) which, in the investigator's judgement, may affect the evaluation of analgesic efficacy. These include, but are not limited to: narcotics (opioids), local anesthetics, non-steroidal anti-inflammatory drugs (NSAIDs), sedative-hypnotics, non-benzodiazepines, sedative anesthetics, glucocorticoids (except for topical use), antiepileptics, anxiolytics, antidepressants, as well as Chinese herbal medicines or proprietary Chinese medicines with sedative or analgesic effects; 12. Use of strong CYP1A2 inhibitors for less than 5 half-lives before randomization (e.g., atazanavir, ciprofloxacin, enoxacin, fluvoxamine, ethinylestradiol) ; 13. Subjects with abnormal findings during the screening period (prior to admission) in vital signs, physical examination, 12-lead ECG, or laboratory tests, which in the investigator's judgement make the subject unsuitable for participation in this trial, including:
  • Patientss with poorly controlled blood pressure despite medication: systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg; or systolic blood pressure <90 mmHg;
  • 12-lead ECG: QTcF ≥450 ms for males or ≥470 ms for females, or a history of severe arrhythmias such as second-degree type II or higher atrioventricular block, or a history of cardiac insufficiency;
  • Coagulation function: PT > ULN + 3 seconds and/or APTT > ULN + 10 seconds;
  • Liver function: ALT and/or AST ≥ 2 × ULN; TBIL ≥ 1.5 × ULN; ALB < 30 g/L;
  • Renal function: Cr ≥ 1.5 × ULN;
  • PLT < 80 × 10^9/L;
  • HGB < 90 g/L;
  • Random blood glucose > 11.1 mmol/L. 14. Positive for HBsAg, HCV-Ab, HIV-Ab, or TP-Ab;; 15. Female subjects with a positive pregnancy test or who are breast feeding; fertile subjects who plan to become pregnant, are unwilling or unable to use effective contraception during the trial and within 3 months after administration, or who plan to donate sperm or ova; 16. Patients with a history of drug abuse, substance use, and/or alcoholism within 6 months prior to randomization, (alcoholism is defined as alcohol consumption exceeding 14 units per week:1 unit = 360 mL beer, or 45 mL spirits with 40% alcohol content, or 150 mL wine); 17. Patients who underwent major surgery within 3 months prior to randomization, or surgery that may significantly affect the in vivo metabolism of the investigational product or the evaluation of safety; 18. Patients with blood loss or blood donation exceeding 400 mL, or who received blood transfusion or blood products within 3 months prior to randomization; 19. Patients who participated in any clinical trial of drugs or medical devices within 3 months prior to randomization; 20. Any other conditions judged by the investigator to be unsuitable for participation in this trial.

Treatment and study plan

SYH9089 injection

Drug

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

Ropivacaine hydrochloride

Drug

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

0.9 % sodium chloride

Drug

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

Primary outcomes

  1. Adverse Event Profile

    Time frame: 14 days

    Participants with an Adverse Event through 14 days

Secondary outcomes

  1. Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) at Rest (NRS-R) Pain Intensity Scores

    Time frame: 0 to 120 hours

    The AUC of NRS-R during 0-6 h,0-12 h,0-24 h,0-48 h,0-72 h,0-96 h,0-120 h,24-48 h,48-72 h,24-72 h,72-96 h,and 96-120 h after administration. Pain intensity was assessed on a scale of 0 to 10, where 0=no pain and 10=worst possible pain.

  2. Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) With Activity (NRS-A) Pain Intensity Scores

    Time frame: 0 to 120 hours

    The AUC of NRS-A during 0-6 h,0-12 h,0-24 h,0-48 h,0-72 h,0-96 h,0-120 h,24-48 h,48-72 h,24-72 h,72-96 h,and 96-120 h after administration. Pain intensity was assessed on a scale of 0 to 10, where 0=no pain and 10=worst possible pain.

  3. Cumulative use of rescue analgesics during each period

    Time frame: 0 to 120 hours

    Cumulative amount of rescue analgesics used during 0-6 h,0-12 h,0-24 h,0-48 h,0-72 h,0-96 h,0-120 h,24-48 h,48-72 h,24-72 h,72-96 h,and 96-120 h after administration.

  4. Proportion of participants not requiring rescue analgesia in each period

    Time frame: 0 to 120 hours

    Proportion of participants not requiring rescue analgesia within 0-6 h,0-12 h,0-24 h,0-48 h,0-72 h,0-96 h,0-120 h,24-48 h,48-72 h,24-72 h,72-96 h,and 96-120 h after administration.

  5. Proportion of participants with an NRS-A score ≤ 1 at different time points.

    Time frame: 0 to 120 hours

    Proportion of participants with an NRS-A score ≤ 1 at 6 h, 12 h, 24 h, 48 h, 72 h, 96 h, and 120 h after administration.

  6. Proportion of participants with an NRS-R score ≤ 1 at different time points.

    Time frame: 0 to 120 hours

    Proportion of participants with an NRS-R score ≤ 1 at 6 h, 12 h, 24 h, 48 h, 72 h, 96 h, and 120 h after administration.

  7. Time of first morphine rescue analgesia

    Time frame: 0 to 120 hours

    The time from administration to the first morphine rescue analgesic treatment

  8. Participant's Analgesic Satisfaction Score

    Time frame: 0 to 120 hours

    Participant satisfaction will be assessed at 120 hours after administration.

  9. Investigator Satisfaction Score

    Time frame: 0 to 120 hours

    Investigator satisfaction will be assessed at 120 hours after administration

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trials Information Group officer

CONTACT

[email protected]

86-0311-69085587

Sponsors and collaborators

Lead sponsor

CSPC Ouyi Pharmaceutical Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Apr 9, 2026
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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