Study Evaluating the Safety, Efficacy and Pharmacokinetics of SYH9089 Injection in Patients Under… (NCT07519109) | Clinical Trial Compass
RecruitingPhase 1
Study Evaluating the Safety, Efficacy and Pharmacokinetics of SYH9089 Injection in Patients Undergoing Abdominal Surgery.
China60 participantsStarted 2026-03-30
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
. 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;
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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.