Evaluate the Safety and Efficacy of HL-1186 Tablet for Postoperative Pain Management in Abdominal Surgery
A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase Ⅱa Study to Evaluate the Safety and Efficacy of HL-1186 Tablets for Postoperative Pain Management in Abdominal Surgery
Shanghai Yidian Pharmaceutical Technology Development Co., Ltd.
40 participants
Dec 1, 2025
INTERVENTIONAL
Conditions
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 postoperative pain management in abdominal surgery.
Eligibility
Inclusion Criteria4
- 18 years old ≤ age ≤ 75 years old, gender is not limited.
- 18 kg/m2 ≤ Body Mass Index (BMI) ≤ 30kg/m2.
- Scheduled to undergo abdominal surgeries under general anesthesia.
- Able to understand the research process and the use of pain scales, and communicate effectively with researchers.
Exclusion Criteria7
- 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.
- 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).
- Judgment by the investigator that the participant should not enter the study due to other conditions.
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Interventions
HL-1186 tablet for oral administration.
HL-1186 placebo tablet for oral administration.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07311369