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

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

NCT07147049•Shanghai Yidian Pharmaceutical Technology Development Co., Ltd.

View on ClinicalTrials.gov

Summary

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

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. 18 years old ≤ age ≤ 75 years old, gender is not limited.
•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

•1. Prior history of surgery at the same site, and this may affect pain perception at the surgical site per investigator's judgments.
•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.

Locations (1)

Sichuan Provincial People's Hospital

Chengdu, Sichuan, China

Key Dates

Start Date

August 8, 2025

Primary Completion Date

December 1, 2025

Completion Date

January 1, 2026

Last Updated

December 22, 2025

Enrollment

ESTIMATED participants

Conditions

Moderate to Severe Acute Postoperative Pain

Interventions

HL-1186

DRUG

HL-1186 placebo

DRUG

Contacts

Renhai Yang

CONTACT

021-64311017 clinical_trial@hllife.com.cn