Evaluate the Safety and Efficacy of HL-1186 Tablet for Postoperative Pain Management in Abdominal Surgery

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Yidian Pharmaceutical Technology Development Co., Ltd.

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • HL-1186
  • HL-1186 placebo

Treatment groups

40 Participants
are divided into 2 treatment groups