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
Trial Information
Current as of April 29, 2025
Not yet recruiting
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.
Gender
ALL
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
About Shanghai Haiyan Pharmaceutical Technology Co., Ltd.
Shanghai Haiyan Pharmaceutical Technology Co., Ltd. is a leading biopharmaceutical company based in Shanghai, specializing in the research, development, and commercialization of innovative therapeutic solutions. With a commitment to advancing healthcare, the company focuses on a diverse range of therapeutic areas, including oncology, neurology, and infectious diseases. Leveraging cutting-edge technology and a robust pipeline of clinical trials, Shanghai Haiyan Pharmaceutical aims to deliver high-quality, effective treatments that address unmet medical needs while adhering to stringent regulatory standards. Through strategic collaborations and a dedication to scientific excellence, the company is positioned to make significant contributions to the global pharmaceutical landscape.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Shanghai, , China
Zhengzhou, , China
Shanghai, , China
Nanchang, Jiangxi, China
Changsha, , China
Chengdu, , China
Nanjing, Jiangsu, China
Dongguan, , China
Shijiazhuang, , China
Ningbo, , China
Ch'ang Ch'un, , China
Jinhua, , China
Hangzhou, , China
Mianyang, , China
Chengdu, , China
Chengdu, , China
Quanzhou, , China
Ningbo, Zhejiang, China
Hefei, , China
Dalian, , China
Suzhou, , China
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported