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

NCT07147049 | Recruiting Phase 2

• 1 other identifier: PY-HL-1186-IIa-01
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Moderate to Severe Acute Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  Day 1 to Day 30

Study Arms (2)

HL-1186

EXPERIMENTAL

Participants will be randomized to either the HL-1186 group or placebo group, and administer study drug every 12 hours for 4 consecutive doses

Drug: HL-1186

HL-1186 placebo

PLACEBO COMPARATOR

Participants will be randomized to either the HL-1186 group or placebo group, and administer study drug every 12 hours for 4 consecutive doses

Drug: HL-1186 placebo

Interventions

HL-1186 DRUG

HL-1186 tablet for oral administration.

HL-1186

HL-1186 placebo DRUG

HL-1186 placebo tablet for oral administration.

HL-1186 placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Yidian Pharmaceutical Technology Development Co., Ltd.: lead

Study Sites (1)

Sichuan Provincial People's Hospital

Chengdu, Sichuan, China

RECRUITING

Central Study Contacts

Renhai Yang

CONTACT

021-64311017; clinical_trial@hllife.com.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2025
• First Posted: August 28, 2025
• Study Start: August 8, 2025
• Primary Completion: December 1, 2025
• Study Completion: January 1, 2026
• Last Updated: December 22, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)