Evaluate the Safety and Efficacy of HL-1186 Tablet for Moderate to Severe Acute Pain After 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 moderate to severe acute pain after 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 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.

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.

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.

Trial design

Treatments tested in this trial

  • HL-1186
  • HL-1186 placebo

Treatment groups

72 Participants
are divided into 2 treatment groups