Shanghai Yidian Pharmaceutical Technology Development Co., Ltd.
Phase
Phase 2
Started
2025-08-08
Last updated
2025-12-22
Condition(s) studied
Moderate to Severe Acute Postoperative Pain
Investigational drug(s) / intervention(s)
HL-1186HL-1186 placebo
HL-1186: HL-1186 tablet for oral administration.
HL-1186 placebo: HL-1186 placebo tablet for oral administration.
Study 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 moderate to severe acute pain after surgery.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
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).
Trial sites (1)
Facility
City
Region
Status
Sichuan Provincial People's Hospital
Chengdu
Sichuan
Recruiting
More Shanghai Yidian Pharmaceutical Technology Development Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.