HL-1186 tablets to treat moderate to severe 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

This Phase 2 test will try HL-1186 tablets to see if they reduce moderate to severe postoperative pain in adults having elective orthopedic, abdominal, or thoracic surgery.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 72 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Shanghai Huilun Pharmaceutical Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Chengdu, Sichuan)
• Trial ID: NCT07147049 on ClinicalTrials.gov

What this trial studies

This is a multicenter, randomized, double-blind, placebo-controlled Phase 2 trial testing HL-1186 tablets for adults with moderate to severe acute pain after elective surgery. The study will measure safety, pain relief (using numeric rating scales), and pharmacokinetic parameters compared with placebo. Eligible participants are adults 18–75 years old with BMI between 18 and 30 kg/m2 who report pain of at least 4 on the NRS after specified surgeries. The trial is led by a pharmaceutical sponsor with enrollment at Sichuan Provincial People's Hospital in Chengdu.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18–75 with BMI 18–30 who undergo elective orthopedic, abdominal, or thoracic surgery under general anesthesia and experience postoperative pain of 4 or greater on the NRS.

Not a fit: Patients with prior surgery at the same site affecting pain perception, allergies to study drug components or perioperative agents, use of prohibited medications, prolonged QTc, or who fall outside the age/BMI criteria are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, HL-1186 could offer an additional oral option to reduce moderate-to-severe postoperative pain with characterized safety and dosing information.

How similar studies have performed: Randomized, double-blind, placebo-controlled trials are the standard for postoperative analgesics and many compounds have shown benefit in this setting, but HL-1186 itself appears novel with no published Phase 2 results yet.

Eligibility criteria

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.

Where this trial is running

Chengdu, Sichuan

• Sichuan Provincial People's Hospital — Chengdu, Sichuan, China (Recruiting)

Study contacts

• Study coordinator: Renhai Yang

Conditions Moderate to Severe Acute Postoperative Pain