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

Not Applicable

Recruiting

• Conditions: Moderate to Severe Acute Postoperative Pain
• Interventions: Drug: HL-1186; Drug: HL-1186 placebo

• Registration Number: NCT07147049
• Lead Sponsor: Shanghai Yidian Pharmaceutical Technology Development Co., Ltd.

Brief Summary

This is a multiple-center, randomized, double-blind, placebo-controlled study design evaluating the safety, efficacy, and PK parameter of HL-1186 tablet for moderate to severe acute pain after surgery.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study Start: 2025-08-01
• Study First Submitted: 2025-08-11
• Study First Submitted QC: 2025-08-21
• Last Update Submitted: 2025-08-21
• Study First Posted: 2025-08-28
• Last Update Posted: 2025-08-28
• Primary Completion: 2025-11
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

1. 18 years old ≤ age ≤ 75 years old, gender is not limited.
2. 18 kg/m2 ≤ 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 AV block), 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HL-1186	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 placebo	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

Primary Outcome Measures

Name	Time	Method
SPID48	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 Outcome Measures

Name	Time	Method
Incidence and severity of Adverse Events (AEs), changes from baseline in vital signs, laboratory examination results, etc.	Day 1 to Day 30

Trial Locations

Locations (1)

Sichuan Provincial People's Hospital; 🇨🇳 Chengdu, Sichuan, China