Evaluate the Safety and Efficacy of HL-1186 Tablet for Moderate to Severe Acute Pain After Surgery
NCT ID: NCT07147049
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
72 participants
INTERVENTIONAL
2025-08-08
2026-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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HL-1186
Participants will be randomized to either the HL-1186 group or placebo group, and administer study drug every 12 hours for 4 consecutive doses
HL-1186
HL-1186 tablet for oral administration.
HL-1186 placebo
Participants will be randomized to either the HL-1186 group or placebo group, and administer study drug every 12 hours for 4 consecutive doses
HL-1186 placebo
HL-1186 placebo tablet for oral administration.
Interventions
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HL-1186
HL-1186 tablet for oral administration.
HL-1186 placebo
HL-1186 placebo tablet for oral administration.
Eligibility Criteria
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Inclusion Criteria
2. 18 kg/m2 ≤ Body Mass Index (BMI) ≤ 30kg/m2.
3. Scheduled to undergo one of the following elective surgeries under general anesthesia: Orthopedic surgery, abdominal surgery, or thoracic surgery.
4. Able to understand the research process and the use of pain scales, and communicate effectively with researchers.
5. Participant reported pain of ≥4 on the NRS.
Exclusion Criteria
2. Allergy to any component of the investigational product, to perioperative anesthetic/analgesic/antiemetic agents, or to ≥3 substance allergies.
3. 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.
4. 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.
5. 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.
6. For female participants: Pregnant or lactating (within 1 year postpartum).
7. 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).
8. 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.
9. Judgment by the investigator that the participant should not enter the study due to other conditions.
18 Years
75 Years
ALL
No
Sponsors
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Shanghai Yidian Pharmaceutical Technology Development Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
Countries
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Central Contacts
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Facility Contacts
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Sichuan Provincial People's Hospital
Role: primary
Other Identifiers
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PY-HL-1186-IIa-01
Identifier Type: -
Identifier Source: org_study_id