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.
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.
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.
Parallel
HL-1186
DrugHL-1186 tablet for oral administration.
HL-1186 placebo
DrugHL-1186 placebo tablet for oral administration.
SPID48
SPID48: Time-weighted Sum of the Pain Intensity Difference (SPID) as recorded on an NRS (Numeric Rating Scale, 0 =no pain to 10 =worst possible pain) at rest 0 to 48 hours after the first dose of study drug. The score range was -480 (worst score) to 480 (best score).
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
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