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Clinical Trials/NCT07311369
NCT07311369
Recruiting
Phase 2

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

Shanghai Yidian Pharmaceutical Technology Development Co., Ltd.1 site in 1 country40 target enrollmentStarted: December 1, 2025Last updated:
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InterventionsHL-1186HL-1186 placebo

Overview

Phase
Phase 2
Status
Recruiting
Sponsor
Shanghai Yidian Pharmaceutical Technology Development Co., Ltd.
Enrollment
40
Locations
1
Primary Endpoint
SPID48
OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

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 postoperative pain management in abdominal surgery.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •18 years old ≤ age ≤ 75 years old, gender is not limited.
  • •18 kg/m2 ≤ Body Mass Index (BMI) ≤ 30kg/m
  • •Scheduled to undergo abdominal surgeries under general anesthesia.
  • •Able to understand the research process and the use of pain scales, and communicate effectively with researchers.

Exclusion Criteria

  • •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.
  • •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).
  • •Judgment by the investigator that the participant should not enter the study due to other conditions.

Arms & Interventions

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

Intervention: HL-1186 (Drug)

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

Intervention: HL-1186 placebo (Drug)

Outcomes

Primary Outcomes

SPID48

Time Frame: 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 Outcomes

  • Number of participants with treatment-related adverse events as assessed by CTCAE v5.0(Day 1 to Day 30)

Investigators

Sponsor
Shanghai Yidian Pharmaceutical Technology Development Co., Ltd.
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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