Prevention of Postoperative Nausea and VomitingPhase 2NCT07709897
A Clinical Trial of HRS5580 for Injection Combined With Palonosetron Hydrochloride for the Prevention of Postoperative Nausea and Vomiting
A Phase 2 study testing HRS5580 for injection combined with palonosetron hydrochloride;, HRS5580 for injection combined with palonosetron hydrochloride and HRS5580 for injection blank preparation combined with palonosetron hydrochloride in people with Prevention of Postoperative Nausea and Vomiting, run by Fujian Shengdi Pharmaceutical Co., Ltd. at 2 sites in China.
Trial summary
The study is being conducted to evaluate the efficacy of HRS5580 for injection combined with palonosetron hydrochloride in the prevention of postoperative nausea and vomiting, and to explore the effective dose of HRS5580 for injection combined with palonosetron hydrochloride for the prevention of postoperative nausea… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prevention of Postoperative Nausea and Vomiting
- What is being tested?
- HRS5580 for injection combined with palonosetron hydrochloride;, HRS5580 for injection combined with palonosetron hydrochloride and HRS5580 for injection blank preparation combined with palonosetron hydrochloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 260 participants
- Where
- 2 sitesChina
- Study dates
- 6 Aug 2026to Dec 2026
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily sign the informed consent form prior to the start of any trial-related activities, fully understand the purpose and significance of the study, and voluntarily comply with the trial procedures;
- 2、Scheduled to undergo elective surgery under general anesthesia with an expected surgical duration of ≥ 2 hours (surgery types include gynecological surgery, hepatobiliary surgery, intestinal surgery, urological surgery, etc.);
- Aged ≥ 18 years;
- Body Mass Index (BMI) between 18 kg/m² and 28 kg/m² (inclusive);
- American Society of Anesthesiologists (ASA) Physical Status Classification I or II;
- Expected postoperative hospital stay ≥ 72 hours;
- Presence of ≥ 3 risk factors for PONV (female, history of PONV or motion sickness, non-smoker, postoperative opioid use);
- Female participants of childbearing potential must have a negative serum pregnancy test within 7 days prior to randomization and must not be breastfeeding; female participants of childbearing potential must use highly effective contraceptive measures (see Appendix 13.1.2) from 30 days prior to the screening period until 6 months after the last dose, and have no plans for egg donation or pregnancy; male participants with a female partner of childbearing potential must use highly effective contraceptive measures from the time of signing the informed consent form until 6 months after the last dose.
Who cannot join
- Patients with a history of vestibular disorders (including but not limited to: peripheral vestibular syndrome, central vestibular syndrome, etc.) or dizziness (excluding history of motion sickness), or a history of central nervous system disorders that may cause nausea and vomiting;
- History of chronic nausea or vomiting/retching;
- History of new-onset myocardial infarction or unstable angina pectoris within 6 months prior to screening, or history of severe cardiac arrhythmias such as second-degree or higher atrioventricular block, or history of New York Heart Association (NYHA) Functional Classification Class II or higher;
- Any other medical condition that, in the investigator's judgment, may confound the assessment of postoperative nausea and/or vomiting.
- Random blood glucose > 11.1 mmol/L during the screening period;
- Prolonged QTc interval during the screening period: > 450 ms in males, > 470 ms in females;
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- Systolic blood pressure ≥ 160 mmHg or < 90 mmHg, and/or diastolic blood pressure ≥ 100 mmHg or < 60 mmHg from the time of signing the ICF to before entering the operating room, which is considered clinically significant by the investigator;
- Abnormal liver function during the screening period: aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) and/or gamma-glutamyl transferase (GGT) ≥ 3.0 × ULN and/or total bilirubin (TBIL) ≥ 1.5 × ULN;
- Abnormal renal function during the screening period: serum creatinine (Cr) ≥ 1.5 × ULN and/or participants undergoing dialysis;
- Positive test for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCVAb), syphilis antibody, or human immunodeficiency virus (HIV) antibody during the screening period;
- Known allergy or contraindication to NK-1 receptor antagonists and/or 5-HT3 receptor antagonists and other medications that may be used during the trial;
- Receipt of any treatment with potential antiemetic effects, including pharmacological and non-pharmacological treatments, within 48 hours prior to the start of investigational product administration (refer to the Prohibited Concomitant Treatments table);
- Participants whose last use of an opioid occurred less than 5 half-lives before the start of investigational product administration;
- Use of strong CYP3A4 inducers, strong inhibitors, or specific CYP2D6 substrates within 28 days prior to randomization.
- Participants who have received chemotherapy within 4 weeks prior to surgery;
- Use of other medications that may affect antiemetic efficacy as determined by the investigator, with the last use occurring less than 5 half-lives before the start of investigational product administration (based on the actual drug label; if the half-life is unknown, a 48-hour washout period should be applied).
- Participants scheduled to receive anesthetic methods not specified in the protocol, including local anesthesia, regional anesthesia [e.g., nerve block, neuraxial block (including subarachnoid block, epidural anesthesia, or combined spinal-epidural anesthesia)], and total intravenous anesthesia;
- Participants expected to require an in-place nasogastric tube or orogastric tube after surgery completion;
- Participants expected to be transferred to the ICU for sedation with endotracheal intubation after surgery or those unable to undergo nausea and vomiting record assessments;
- Participation in another clinical study of a drug or device within 3 months prior to screening (having signed informed consent and received investigational product/device treatment);
- Daily excessive consumption of tea, coffee, grapefruit/grapefruit juice, pomelo juice, or caffeinated beverages (average > 8 cups per day, 200 mL per cup) within 14 days prior to randomization;
- Any other condition that, in the investigator's opinion, makes the participant unsuitable for participation in this trial.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Fudan University Zhongshan Hospital
Shanghai, Shanghai Municipality, 200032
Changhong Miao
- Recruiting
Tianjin Nankai Hospital
Tianjin, Tianjin Municipality, 300100
Jianbo Yu
About this study
Official title: A Multicenter, Randomized, Dose-finding, Positive-controlled, Double-blind, Double-dummy Phase II Clinical Trial to Evaluate the Efficacy and Safety of HRS5580 for Injection Combined With Palonosetron Hydrochloride in the Prevention of Postoperative Nausea and Vomiting
The study is being conducted to evaluate the efficacy of HRS5580 for injection combined with palonosetron hydrochloride in the prevention of postoperative nausea and vomiting, and to explore the effective dose of HRS5580 for injection combined with palonosetron hydrochloride for the prevention of postoperative nausea and vomiting.
- Being tested
- HRS5580 for injection combined with palonosetron hydrochloride;, HRS5580 for injection combined with palonosetron hydrochloride, HRS5580 for injection blank preparation combined with palonosetron hydrochloride
- Medical subject headings
- Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS5580 for injection combined with palonosetron hydrochloride;Drug
HRS5580 for injection combined with palonosetron hydrochloride; low dose
HRS5580 for injection combined with palonosetron hydrochlorideDrug
HRS5580 for injection combined with palonosetron hydrochloride; high dose
HRS5580 for injection blank preparation combined with palonosetron hydrochlorideDrug
HRS5580 for injection blank preparation combined with palonosetron hydrochloride
| Study group | Role | What they receive |
|---|---|---|
| Treatment group A: HRS5580 for injection combined with palonosetron hydrochloride | Experimental | Not described Receives: Drug: HRS5580 for injection combined with palonosetron hydrochloride; |
| Treatment group B: HRS5580 for injection combined with palonosetron hydrochloride | Experimental | Not described Receives: Drug: HRS5580 for injection combined with palonosetron hydrochloride |
| Treatment group C | Placebo comparator | Not described Receives: Drug: HRS5580 for injection blank preparation combined with palonosetron hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete response rate within 72 hours after extubation (defined as the proportion of participants with no vomiting and no use of rescue therapy)
Measured: within 72 hours after extubation
Secondary outcomes (11)
Complete response rate within 24hours, 48hours, 24-48hours, 24-72hours, 96hours, and 120hours after extubation
Measured: within 24hours, 48hours, 24-48hours, 24-72hours, 96hours, and 120hours after extubation
Vomiting-free rate within 24hours, 48hours, 24-48hours, 72hours, 24-72hours, 96hours, and 120hours after extubation
Measured: within 24hours, 48hours, 24-48hours, 72hours, 24-72hours, 96hours, and 120hours after extubation
Nausea-free rate within 24hours, 48hours, 24-48hours, 72hours, 24-72hours, 96hours, and 120hours after extubation
Measured: within 24hours, 48hours, 24-48hours, 72hours, 24-72hours, 96hours, and 120hours after extubation
PONV （postoperative nausea and vomiting）rate within 24hours, 48hours, 24-48hours, 72hours, 24-72hours, 96hours, and 120hours after extubation
Measured: within 24hours, 48hours, 24-48hours, 72hours, 24-72hours, 96hours, and 120hours after extubation
Proportion of participants without significant nausea within 24hours, 48hours, 24-48hours, 72hours, 24-72hours, 96hours, and 120hours after extubation
Measured: within 24hours, 48hours, 24-48hours, 72hours, 24-72hours, 96hours, and 120hours after extubation
Nausea severity score within 24hours, 48hours, 24-48hours, 72hours, 24-72hours, 96hours, and 120hours after extubation (assessed based on the worst nausea severity during each time interval)
Measured: within 24hours, 48hours, 24-48hours, 72hours, 24-72hours, 96hours, and 120hours after extubation (assessed based on the worst nausea severity during each time interval)
Proportion of participants without rescue therapy within 24hours, 48hours, 24-48hours, 72hours, 24-72hours, 96hours, and 120hours after extubation
Measured: without rescue therapy within 24hours, 48hours, 24-48hours, 72hours, 24-72hours, 96hours, and 120hours after extubation
Time to first vomiting after extubation
Measured: Post-extubation 0-120 hours
Time to first significant nausea after extubation
Measured: Post-extubation 0-120 hours
Time to first rescue therapy after extubation
Measured: Post-extubation 0-120 hours
Investigator satisfaction score at 120 hours after extubation
Measured: Investigator satisfaction score at 120 hours after extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study start6 Aug 2026
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prevention of Postoperative Nausea and VomitingStudies of the same condition, open and under way.
- More trials run by Fujian Shengdi 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07709897
- Sponsor's protocol ID
- HRS5580-202
- Status last verified
- Jul 2026
- First submitted
- 8 Jul 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Dose-finding, Positive-controlled, Double-blind, Double-dummy Phase II Clinical Trial to Evaluate the Efficacy and Safety of HRS5580 for Injection Combined With Palonosetron Hydrochloride in the Prevention of Postoperative Nausea and Vomiting
- ClinicalTrials.gov ID
- NCT07709897
- Acronym / sponsor ID
- HRS5580-202
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Aug 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 17 Jul 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.
The study is being conducted to evaluate the efficacy of HRS5580 for injection combined with palonosetron hydrochloride in the prevention of postoperative nausea and vomiting, and to explore the effective dose of HRS5580 for injection combined with palonosetron hydrochloride for the prevention of postoperative nausea and vomiting.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment group A: HRS5580 for injection combined with palonosetron hydrochloride | Experimental | Drug: HRS5580 for injection combined with palonosetron hydrochloride; |
| Treatment group B: HRS5580 for injection combined with palonosetron hydrochloride | Experimental | Drug: HRS5580 for injection combined with palonosetron hydrochloride |
| Treatment group C | Placebo comparator | Drug: HRS5580 for injection blank preparation combined with palonosetron hydrochloride |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Voluntarily sign the informed consent form prior to the start of any trial-related activities, fully understand the purpose and significance of the study, and voluntarily comply with the trial procedures;
- 2、Scheduled to undergo elective surgery under general anesthesia with an expected surgical duration of ≥ 2 hours (surgery types include gynecological surgery, hepatobiliary surgery, intestinal surgery, urological surgery, etc.);
- Aged ≥ 18 years;
- Body Mass Index (BMI) between 18 kg/m² and 28 kg/m² (inclusive);
- American Society of Anesthesiologists (ASA) Physical Status Classification I or II;
Key exclusion criteria (22 listed)
- Patients with a history of vestibular disorders (including but not limited to: peripheral vestibular syndrome, central vestibular syndrome, etc.) or dizziness (excluding history of motion sickness), or a history of central nervous system disorders that may cause nausea and vomiting;
- History of chronic nausea or vomiting/retching;
- History of new-onset myocardial infarction or unstable angina pectoris within 6 months prior to screening, or history of severe cardiac arrhythmias such as second-degree or higher atrioventricular block, or history of New York Heart Association (NYHA) Functional Classification Class II or higher;
- Any other medical condition that, in the investigator's judgment, may confound the assessment of postoperative nausea and/or vomiting.
- Random blood glucose > 11.1 mmol/L during the screening period;
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 |
|---|---|---|
| HRS5580 for injection combined with palonosetron hydrochloride;HRS5580 for injection combined with palonosetron hydrochloride; low dose | Drug | Treatment group A: HRS5580 for injection combined with palonosetron hydrochloride |
| HRS5580 for injection combined with palonosetron hydrochlorideHRS5580 for injection combined with palonosetron hydrochloride; high dose | Drug | Treatment group B: HRS5580 for injection combined with palonosetron hydrochloride |
| HRS5580 for injection blank preparation combined with palonosetron hydrochlorideHRS5580 for injection blank preparation combined with palonosetron hydrochloride | Drug | Treatment group C |
Primary outcome
Complete response rate within 72 hours after extubation (defined as the proportion of participants with no vomiting and no use of rescue therapy)
Time frame: within 72 hours after extubation
11 secondary outcomes
Complete response rate within 24hours, 48hours, 24-48hours, 24-72hours, 96hours, and 120hours after extubation
Time frame: within 24hours, 48hours, 24-48hours, 24-72hours, 96hours, and 120hours after extubation
Vomiting-free rate within 24hours, 48hours, 24-48hours, 72hours, 24-72hours, 96hours, and 120hours after extubation
Time frame: within 24hours, 48hours, 24-48hours, 72hours, 24-72hours, 96hours, and 120hours after extubation
Nausea-free rate within 24hours, 48hours, 24-48hours, 72hours, 24-72hours, 96hours, and 120hours after extubation
Time frame: within 24hours, 48hours, 24-48hours, 72hours, 24-72hours, 96hours, and 120hours after extubation
PONV （postoperative nausea and vomiting）rate within 24hours, 48hours, 24-48hours, 72hours, 24-72hours, 96hours, and 120hours after extubation
Time frame: within 24hours, 48hours, 24-48hours, 72hours, 24-72hours, 96hours, and 120hours after extubation
Proportion of participants without significant nausea within 24hours, 48hours, 24-48hours, 72hours, 24-72hours, 96hours, and 120hours after extubation
Time frame: within 24hours, 48hours, 24-48hours, 72hours, 24-72hours, 96hours, and 120hours after extubation
Nausea severity score within 24hours, 48hours, 24-48hours, 72hours, 24-72hours, 96hours, and 120hours after extubation (assessed based on the worst nausea severity during each time interval)
Time frame: within 24hours, 48hours, 24-48hours, 72hours, 24-72hours, 96hours, and 120hours after extubation (assessed based on the worst nausea severity during each time interval)
Proportion of participants without rescue therapy within 24hours, 48hours, 24-48hours, 72hours, 24-72hours, 96hours, and 120hours after extubation
Time frame: without rescue therapy within 24hours, 48hours, 24-48hours, 72hours, 24-72hours, 96hours, and 120hours after extubation
Time to first vomiting after extubation
Time frame: Post-extubation 0-120 hours
Time to first significant nausea after extubation
Time frame: Post-extubation 0-120 hours
Time to first rescue therapy after extubation
Time frame: Post-extubation 0-120 hours
Investigator satisfaction score at 120 hours after extubation
Time frame: Investigator satisfaction score at 120 hours after extubation
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 26 Aug 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Prevention of Postoperative Nausea and Vomiting
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Amisulpride Injection for the Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Surgery
PONV
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Efficacy of Adding Oral Amisulpride to Dual Prophylaxis for Postoperative Nausea and Vomiting in Patients at High Risk for Nausea and Vomiting Undergoing Gynecological Surgery
Post Operative Nausea and Vomiting (PONV)
Not yet recruitingPhase 4
Sleep Quality - Comparing the Effect of Ondansetron or Dexamethasone Given as Routine Prophylaxis Intraoperatively to Prevent Post Operative Nausea and Vomiting (SCORPION)
Postoperative Sleep Quality, Postoperative Behaviour
RecruitingPhase 3
MELAtonin for Prevention of Postoperative Agitation and Emergence Delirium in Children
Emergence Delirium
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Use of Transcutaneous Electrical Nerve Stimulation Device, Reletex Reliefband, With Current ERAS (Enhanced Recovery After Surgery) Protocol to Further Decrease Postoperative Nausea and Vomiting in the Bariatric Surgical Patient Within the First 24 Hours Postoperatively.
Postoperative Nausea and Vomiting, Bariatric Sleeve Gastrectomy
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HRS5580 for injection combined with palonosetron hydrochloride;, HRS5580 for injection combined with palonosetron hydrochloride and HRS5580 for injection blank preparation combined with palonosetron hydrochloride in people with Prevention of Postoperative Nausea and Vomiting, run by Fujian Shengdi Pharmaceutical Co., Ltd. at 2 sites 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 8 inclusion and 22 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 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Lei Tang (+0518-82342973, lei.tang.lt31@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete response rate within 72 hours after extubation (defined as the proportion of participants with no vomiting and no use of rescue therapy) (time frame: within 72 hours after extubation). 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 26 Aug 2026.