Evaluate the Safety and Efficacy of HL-1186 Tablet for Postoperative Analgesia in Orthopedic Surgery

A Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled Parallel-Group Phase II/III Clinical Trial to Evaluate the Efficacy and Safety of HL-1186 Tablets for Postoperative Analgesia in Orthopedic Surgery

This clinical trial is a multiple-center, randomized, double-blind, placebo- and active-controlled parallel-group Phase II/III clinical trial, to evaluate the efficacy and safety of HL-1186 Tablets for Postoperative Analgesia in Orthopedic Surgery.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Pain
• Intervention / Treatment: Drug: HL-1186; Drug: HL-1186 placebo; Drug: Oxycodone-Acetaminophen Matching Placebo; Drug: Oxycodone-Acetaminophen

• Study Type: Interventional
• Enrollment (Estimated): 330
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: MeiXuan Li; Phone Number: 021-64311017; Email: clinical_trial@hllife.com.cn

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China
      • Recruiting
      • The Third Xiangya Hospital of Central South University, Changsha, Hunan
      • Contact: The Third Xiangya Hospital of Central South University; Phone Number: +86-0731-88618938; Email: xy3irb@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 orthopedic surgery under general anesthesia, with expected moderate-to-severe postoperative pain intensity.
4. Able to understand the research process and the use of pain scales, and communicate effectively with researchers.
5. After surgery completion, the participant is judged by the investigator to be awake and has a resting NRS score ≥ 4.

Exclusion Criteria:

1. Previous surgery on the same site that may affect pain perception at the surgical site.
2. Paresthesia or other pain that may affect postoperative pain evaluation or scale assessment.
3. Neuropsychological disorders that may affect postoperative pain evaluation or scale assessment.
4. Unstable angina, myocardial infarction, severe arrhythmia, NYHA cardiac function class ≥ III, or recurrent asthma attacks, etc., deemed unsuitable for inclusion by the investigator.
5. Poorly controlled hypertension.
6. Sleep apnea syndrome, or the presence of a difficult airway as assessed by the investigator.
7. Known allergy to any component of the investigational drug(s), to perioperative (from induction of anesthesia to completion of surgery) anesthetic/analgesic/antiemetic drugs, or a history of allergy to ≥ 3 substances.
8. Positive for human immunodeficiency virus (HIV) antibody; positive for Treponema pallidum antibody and positive toluidine red unheated serum test (TRUST); positive for hepatitis B surface antigen (HBsAg) with detectable HBV-DNA; or positive for hepatitis C virus (HCV) antibody.
9. Women who are pregnant or breastfeeding (within 1 year after delivery).
10. Participation in another drug or medical device trial within 1 month before screening, or currently participating in another clinical trial receiving investigational intervention.
11. Any other condition considered unsuitable for participation by the investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HL-1186 High-Dose Group; Participants will be randomized to either the HL-1186 groups, placebo group or active-comparator group, and administer study drug every 6 hours	Drug: HL-1186; HL-1186 tablet for oral administration.; Drug: Oxycodone-Acetaminophen Matching Placebo; Oxycodone-Acetaminophen Matching Placebo for oral adminstration
Experimental: HL-1186 Low-Dose Group; Participants will be randomized to either the HL-1186 groups, placebo group or active-comparator group, and administer study drug every 6 hours	Drug: HL-1186; HL-1186 tablet for oral administration.; Drug: HL-1186 placebo; HL-1186 placebo tablet for oral administration.; Drug: Oxycodone-Acetaminophen Matching Placebo; Oxycodone-Acetaminophen Matching Placebo for oral adminstration
Active Comparator: Oxycodone-Acetaminophen Group; Participants will be randomized to either the HL-1186 groups, placebo group or active-comparator group, and administer study drug every 6 hours	Drug: HL-1186 placebo; HL-1186 placebo tablet for oral administration.; Drug: Oxycodone-Acetaminophen; Oxycodone-Acetaminophen for oral adminstration
Placebo Comparator: Placebo Group; Participants will be randomized to either the HL-1186 groups, placebo group or active-comparator group, and administer study drug every 6 hours	Drug: HL-1186 placebo; HL-1186 placebo tablet for oral administration.; Drug: Oxycodone-Acetaminophen Matching Placebo; Oxycodone-Acetaminophen Matching Placebo for oral adminstration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	0 to 48 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of participants with treatment-related adverse events	0-9 days

Collaborators and Investigators

• Sponsor: Shanghai Huilun Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: April 26, 2026
• First Submitted That Met QC Criteria: July 8, 2026
• First Posted (Actual): July 13, 2026

Study Record Updates

• Last Update Posted (Actual): July 13, 2026
• Last Update Submitted That Met QC Criteria: July 8, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; oxycodone-acetaminophen
• Other Study ID Numbers: PY-HL-1186-OS-302

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No