Evaluate the Safety and Efficacy of HL-1186 Tablet for Moderate to Severe Acute Pain After Surgery

Официальное название

A Phase 2a, Randomized, Double-blind, Placebo-controlled, Parallel Study Evaluating the Safety and Efficacy of HL-1186 Tablet for Moderate to Severe Acute Pain After Surgery

Обзор

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.

Вмешательства

• Препарат HL-1186
  HL-1186 tablet for oral administration.
• Препарат HL-1186 placebo
  HL-1186 placebo tablet for oral administration.

Первичные конечные точки

• SPID48 [Срок оценки: 0 to 48 hours]

Вторичные конечные точки (1)

• Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 [Срок оценки: Day 1 to Day 30]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Sichuan Provincial People's Hospital — Чэнду

Идентификаторы

NCT: NCT07147049 · PY-HL-1186-IIa-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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