A Study of YZJ-4729 Tartrate Injection for the Treatment of Pain After Orthopedic Surgery

Launched by SHANGHAI HAIYAN PHARMACEUTICAL TECHNOLOGY CO., LTD. · Mar 24, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called YZJ-4729 Tartrate Injection to help relieve pain after orthopedic surgery, which is surgery on bones and joints. The main goal is to see how well this injection works to reduce pain and to make sure it is safe for patients. The trial is not yet recruiting participants, but when it begins, it will welcome adults aged 18 to 75 who have moderate to severe pain after their surgery.

To be eligible for the study, participants will need to understand the purpose of the trial and agree to take part by signing a consent form. They should also have a body mass index (BMI) between 18 and 28, and their pain level must be at least a 4 on a scale of 0 to 10 within four hours after surgery. However, people with certain health conditions, such as allergies to opioids, serious nervous system issues, or high blood pressure, may not be able to participate. Those who join can expect to receive the injection and be monitored for its effects on their pain and overall health.

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Eligibility criteria

• Inclusion Criteria:
• • 1. Be able to understand the study purpose and cooperate with the study procedures of this trial, voluntarily provide written informed consent
• • 2. BMI≥18.0 kg/m2 and ≤28.0 kg/m2
• • 3. ASA I to II
• • 4. Experiences a pain intensity rating of moderate to severe acute pain following orthopedic surgery, with a pain intensity score of ≥4 on a Numeric Rating Scale (NRS) within 4 hours post-surgery
• Exclusion Criteria:
• • 1. Opioid allergy
• • 2. Nervous system diseases (e.g. epilepsy)
• • 3. Psychiatric disorders (e.g. depression)
• • 4. History of difficult airways
• • 5. Random blood glucose ≥11.1 mmol/L
• • 6. Subjects with systolic blood pressure \>160 mmHg and/or diastolic blood pressure \>100 mmHg or systolic blood pressure \< 90 mmHg
• • 7. Abnormal pulse oxygen saturation (SpO2 \<92 %)
• • 8. Abnormal liver function or renal function
• • 9. Used agents that could affect the analgesic response
• • 10. Used agents that could affect drug metabolism
• • 11. Has previously participated in another YZJ-4729 clinical study