NCT07147049 Evaluate the Safety and Efficacy of HL-1186 Tablet for Moderate to Severe Acute Pain After Surgery
| NCT ID | NCT07147049 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Shanghai Yidian Pharmaceutical Technology Development Co., Ltd. |
| Condition | Moderate to Severe Acute Postoperative Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 72 participants |
| Start Date | 2025-08-08 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 72 participants in total. It began in 2025-08-08 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 moderate to severe acute pain after surgery.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07147049 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Moderate to Severe Acute Postoperative Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07147049 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07147049 currently recruiting?
Yes, NCT07147049 is actively recruiting participants. Contact the research team at clinical_trial@hllife.com.cn for enrollment information.
Where is the NCT07147049 trial being conducted?
This trial is being conducted at Chengdu, China.
Who is sponsoring the NCT07147049 clinical trial?
NCT07147049 is sponsored by Shanghai Yidian Pharmaceutical Technology Development Co., Ltd.. The trial plans to enroll 72 participants.