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Postoperative PainPhase 1NCT07519109

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

A Phase 1 study testing SYH9089 injection, Ropivacaine hydrochloride and 0.9 % sodium chloride in people with Postoperative Pain, run by CSPC Ouyi Pharmaceutical Co., Ltd. at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Postoperative Pain
What is being tested?
SYH9089 injection, Ropivacaine hydrochloride and 0.9 % sodium chloride
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteChina
Study dates
30 Mar 2026to 31 Mar 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Clinical Trials Information Group officer contact

86-0311-69085587

ctr-contact@cspc.cn

China1 site, 1 recruiting
  • The Third Xiangya Hospital of Central South University

    Changsha, Hunan, 410013

    Wen Ouyang, M.D., 0731-8861815, ouyangwen139@126.com

    Guoping Yang, PhD, 0731-89918665, ygp9880@163.com

    Recruiting

Other trials in China

About this study

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

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.

Being tested
SYH9089 injection, Ropivacaine hydrochloride, 0.9 % sodium chloride
Medical subject headings
Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SYH9089 injectionDrug

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

  • Ropivacaine hydrochlorideDrug

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

  • 0.9 % sodium chlorideDrug

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

Study groups in NCT07519109
Study groupRoleWhat they receive
SYH9089 injectionExperimentalNot described
Receives: Drug: SYH9089 injection
Ropivacaine hydrochlorideActive comparatorNot described
Receives: Drug: Ropivacaine hydrochloride
0.9 % sodium chloridePlacebo comparatorNot described
Receives: Drug: 0.9 % sodium chloride

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse Event Profile

    Participants with an Adverse Event through 14 days

    Measured: 14 days

Secondary outcomes (9)
  1. Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) at Rest (NRS-R) Pain Intensity Scores

    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.

    Measured: 0 to 120 hours

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

    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.

    Measured: 0 to 120 hours

  3. Cumulative use of rescue analgesics during each period

    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.

    Measured: 0 to 120 hours

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

    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.

    Measured: 0 to 120 hours

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

    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.

    Measured: 0 to 120 hours

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

    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.

    Measured: 0 to 120 hours

  7. Time of first morphine rescue analgesia

    The time from administration to the first morphine rescue analgesic treatment

    Measured: 0 to 120 hours

  8. Participant's Analgesic Satisfaction Score

    Participant satisfaction will be assessed at 120 hours after administration.

    Measured: 0 to 120 hours

  9. Investigator Satisfaction Score

    Investigator satisfaction will be assessed at 120 hours after administration

    Measured: 0 to 120 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Apr 2026
  2. Study start30 Mar 2026
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Mar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a randomized, double-blind, parallel-group, dose-escalation study. Sixty subjects scheduled for abdominal surgery will be enrolled and equally allocated to 5 dose groups (12 subjects per group). Within each group, subjects will be randomly assigned in a 4:1:1 ratio to receive SYH9089, active comparator, or placebo.
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07519109
Sponsor's protocol ID
SYH9089-001
Status last verified
May 2026
First submitted
2 Apr 2026
Last updated
15 Jul 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SYH9089 injection, Ropivacaine hydrochloride and 0.9 % sodium chloride in people with Postoperative Pain, run by CSPC Ouyi Pharmaceutical Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Clinical Trials Information Group officer (86-0311-69085587, ctr-contact@cspc.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse Event Profile (time frame: 14 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.

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