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

Shanghai Yidian Pharmaceutical Technology Development

Status and phase: Enrolling; Phase 2

Conditions: Moderate to Severe Acute Postoperative Pain

Treatments: Drug: HL-1186 placebo; Drug: HL-1186

Study type: Interventional

Funder types: Industry

Identifiers

NCT07147049

PY-HL-1186-IIa-01

Details and patient eligibility

About

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.

Enrollment: 72 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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72 participants in 2 patient groups, including a placebo group

HL-1186

Experimental group

Description:

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

Treatment:

Drug: HL-1186

HL-1186 placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: HL-1186 placebo