HL-1186 tablets for reducing pain after abdominal surgery

A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase Ⅱa Study to Evaluate the Safety and Efficacy of HL-1186 Tablets for Postoperative Pain Management in Abdominal Surgery

This trial will test whether HL-1186 tablets reduce moderate to severe pain after abdominal surgery in adults aged 18–75.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Shanghai Huilun Pharmaceutical Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Changsha, Hunan)
• Trial ID: NCT07311369 on ClinicalTrials.gov

What this trial studies

This is a phase 2, randomized, double-blind, placebo-controlled, multi-center trial comparing oral HL-1186 tablets to matching placebo in adults undergoing abdominal surgery under general anesthesia. The trial will collect safety data, measure postoperative pain outcomes, and analyze pharmacokinetic (PK) parameters of HL-1186. Eligible participants are adults 18–75 years old with BMI 18–30 kg/m2 who can use pain scales and communicate with researchers. Treatments and pain scores will be monitored in the immediate postoperative period to detect differences in pain relief and adverse events.

Who should consider this trial

Good fit: Adults aged 18–75 with BMI 18–30 kg/m2 who are scheduled for abdominal surgery under general anesthesia and can use pain scales and communicate with study staff are the ideal candidates.

Not a fit: Patients with prior surgery at the same site, significant cardiac disease, high bleeding risk, multiple allergies to study medications, or BMI outside the specified range are unlikely to benefit or are excluded.

Why it matters

Potential benefit: If successful, HL-1186 could provide better short-term pain control after abdominal surgery and potentially reduce reliance on stronger analgesics.

How similar studies have performed: Oral non-opioid analgesics have shown mixed success in randomized placebo-controlled settings, and HL-1186 represents a novel compound that has not yet been proven in larger trials.

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 abdominal surgeries under general anesthesia.
4. Able to understand the research process and the use of pain scales, and communicate effectively with researchers.

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. 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.
4. 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.
5. For female participants: Pregnant or lactating (within 1 year postpartum).
6. 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).
7. Judgment by the investigator that the participant should not enter the study due to other conditions.

Where this trial is running

Changsha, Hunan

• The Third Xiangya Hospital of Central South University — Changsha, Hunan, China (Recruiting)

Study contacts

• Study coordinator: Renhai Yang

Conditions Moderate to Severe Acute Postoperative Pain