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.
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.
China1 site, 1 recruiting
- 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
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.
- Conditions
- Postoperative Pain
- 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 group | Role | What they receive |
|---|---|---|
| SYH9089 injection | Experimental | Not described Receives: Drug: SYH9089 injection |
| Ropivacaine hydrochloride | Active comparator | Not described Receives: Drug: Ropivacaine hydrochloride |
| 0.9 % sodium chloride | Placebo comparator | Not described Receives: Drug: 0.9 % sodium chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Event Profile
Participants with an Adverse Event through 14 days
Measured: 14 days
Secondary outcomes (9)
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
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
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
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
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
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
Time of first morphine rescue analgesia
The time from administration to the first morphine rescue analgesic treatment
Measured: 0 to 120 hours
Participant's Analgesic Satisfaction Score
Participant satisfaction will be assessed at 120 hours after administration.
Measured: 0 to 120 hours
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.
- First posted9 Apr 2026
- Study start30 Mar 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by CSPC Ouyi Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- CSPC Ouyi Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wen Ouyang, MD, Principal investigator, The Third Xiangya Hospital of Central South UniversityGuoping Yang, PhD, Principal investigator, The Third Xiangya Hospital of Central South University
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
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07519109
- Acronym / sponsor ID
- SYH9089-001
- Conditions
- Postoperative Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- CSPC Ouyi Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Mar 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 9 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| SYH9089 injection | Experimental | Drug: SYH9089 injection |
| Ropivacaine hydrochloride | Active comparator | Drug: Ropivacaine hydrochloride |
| 0.9 % sodium chloride | Placebo comparator | Drug: 0.9 % sodium chloride |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (9 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SYH9089 injectionBefore the surgical incision was closed, SYH9089 injection was applied to the incision wound. | Drug | SYH9089 injection |
| Ropivacaine hydrochlorideBefore the surgical incision was closed, 0.5% ropivacaine hydrochloride was injected into the incision wound. | Drug | Ropivacaine hydrochloride |
| 0.9 % sodium chlorideBefore the surgical incision was closed, the incision wound was infiltrated with 0.9% sodium chloride injection. | Drug | 0.9 % sodium chloride |
Primary outcome
Adverse Event Profile
Time frame: 14 days
Participants with an Adverse Event through 14 days
9 secondary outcomes
Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) at Rest (NRS-R) Pain Intensity Scores
Time frame: 0 to 120 hours
Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) With Activity (NRS-A) Pain Intensity Scores
Time frame: 0 to 120 hours
Cumulative use of rescue analgesics during each period
Time frame: 0 to 120 hours
Proportion of participants not requiring rescue analgesia in each period
Time frame: 0 to 120 hours
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-R score ≤ 1 at different time points.
Time frame: 0 to 120 hours
Time of first morphine rescue analgesia
Time frame: 0 to 120 hours
Participant's Analgesic Satisfaction Score
Time frame: 0 to 120 hours
Investigator Satisfaction Score
Time frame: 0 to 120 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wen Ouyang, MD principal investigator
The Third Xiangya Hospital of Central South University
Guoping Yang, PhD principal investigator
The Third Xiangya Hospital of Central South University
1 site in 1 country: see every site and its status.
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.