A Clinical Trial of HRS5580 for Injection Combined With Palonosetron Hydrochloride for the Prevention of Postoperative Nausea and Vomiting

NCT07709897 | Recruiting Phase 2

• 1 other identifier: HRS5580-202
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 2

Brief 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 and vomiting.

Conditions

Prevention of Postoperative Nausea and Vomiting

Outcome Measures

Primary Outcomes (1)

• Complete response rate within 72 hours after extubation (defined as the proportion of participants with no vomiting and no use of rescue therapy)

  within 72 hours after extubation

Secondary Outcomes (11)

• Complete response rate within 24hours, 48hours, 24-48hours, 24-72hours, 96hours, and 120hours after extubation

  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

  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

  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

  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

  within 24hours, 48hours, 24-48hours, 72hours, 24-72hours, 96hours, and 120hours after extubation

Study Arms (3)

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

Interventions

HRS5580 for injection blank preparation combined with palonosetron hydrochloride DRUG

HRS5580 for injection blank preparation combined with palonosetron hydrochloride

Treatment group C

HRS5580 for injection combined with palonosetron hydrochloride DRUG

HRS5580 for injection combined with palonosetron hydrochloride; high dose

Treatment group B: HRS5580 for injection combined with palonosetron hydrochloride

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 、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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Fujian Shengdi Pharmaceutical Co., Ltd.: lead

Study Sites (2)

Fudan University Zhongshan Hospital

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Tianjin Nankai Hospital

Tianjin, Tianjin Municipality, 300100, China

RECRUITING

MeSH Terms

Conditions

Vomiting

Interventions

Palonosetron

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Lei Tang

CONTACT

+0518-82342973; lei.tang.lt31@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2026
• First Posted: July 17, 2026
• Study Start: August 6, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 26, 2026

Record last verified: 2026-07

Locations

CN (2)