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NCT Number: NCT07147049

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

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.

Recruiting

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sichuan Provincial People's Hospital

Chengdu, Sichuan, China

Location status: Recruiting

Location contact

Sichuan Provincial People's Hospital

CONTACT

[email protected]

+86-028-87393401

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

HL-1186

Drug

HL-1186 tablet for oral administration.

HL-1186 placebo

Drug

HL-1186 placebo tablet for oral administration.

Primary outcomes

  1. SPID48

    Time frame: 0 to 48 hours

    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).

Secondary outcomes

  1. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

    Time frame: Day 1 to Day 30

Study contacts

Contact information is provided by the study sponsor or research team.

Renhai Yang

CONTACT

[email protected]

021-64311017

Sponsors and collaborators

Lead sponsor

Shanghai Yidian Pharmaceutical Technology Development Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Aug 28, 2025
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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