Status:
RECRUITING
Evaluate the Safety and Efficacy of HL-1186 Tablet for Moderate to Severe Acute Pain After Surgery
Lead Sponsor:
Shanghai Yidian Pharmaceutical Technology Development Co., Ltd.
Conditions:
Moderate to Severe Acute Postoperative Pain
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This is a multiple-center, randomized, double-blind, placebo-controlled study design evaluating the safety, efficacy, and pharmacokinetics (PK) parameter of HL-1186 tablet for moderate to severe acute...
Eligibility Criteria
Inclusion
- 18 years old ≤ age ≤ 75 years old, gender is not limited.
- 18 kg/m2 ≤ Body Mass Index (BMI) ≤ 30kg/m2.
- Scheduled to undergo one of the following elective surgeries under general anesthesia: Orthopedic surgery, abdominal surgery, or thoracic surgery.
- Able to understand the research process and the use of pain scales, and communicate effectively with researchers.
- Participant reported pain of ≥4 on the NRS.
Exclusion
- Prior history of surgery at the same site, and this may affect pain perception at the surgical site per investigator's judgments.
- Allergy to any component of the investigational product, to perioperative anesthetic/analgesic/antiemetic agents, or to ≥3 substance allergies.
- Use of the prohibited medications specified in the protocol within 5 half-lives of the drug (or 7 days if half-life is unknown) prior to randomization, and this may affect pain or scale assessments per investigator's judgments.
- QTcF ≥450 ms (using Fridericia correction), unstable angina, myocardial infarction, severe arrhythmias (e.g., third-degree atrioventricular block), New York Heart Association (NYHA) class III or higher cardiac function, recurrent asthma, etc., within screen period, and deemed ineligible per investigator's judgments.
- High bleeding risk conditions: Congenital bleeding disorders (e.g., hemophilia), platelet function abnormalities (e.g., idiopathic thrombocytopenic purpura, disseminated intravascular coagulation, congenital platelet function abnormalities), active bleeding, etc., and deemed ineligible per investigator's judgments.
- For female participants: Pregnant or lactating (within 1 year postpartum).
- Participants with childbearing potential planning conception/sperm/egg donation within 6 months post-treatment, or unwilling to use effective contraception (abstinence, barrier methods, oral contraceptives, intrauterine device, or sterilization).
- Participants who have participated in other investigational product/device studies within 30 days prior to the screening visit, or are currently enrolled in another study.
- Judgment by the investigator that the participant should not enter the study due to other conditions.
Key Trial Info
Start Date :
August 8 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT07147049
Start Date
August 8 2025
End Date
January 1 2026
Last Update
December 22 2025
Active Locations (1)
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1
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China