NCT07758920 A Clinical Trial to Evaluate the Efficacy and Safety of HL-1186 Tablet in the Treatment of Postherpetic Neuralgia
| NCT ID | NCT07758920 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Shanghai Yidian Pharmaceutical Technology Development Co., Ltd. |
| Condition | Postherpetic Neuralgia ( PHN ) |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2026-08 |
| Primary Completion | 2027-06 |
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 200 participants in total. It began in 2026-08 with a primary completion date of 2027-06.
⚠ 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 multicenter, randomized, double-blind, double-dummy, placebo- and active-controlled, parallel-group trial to evaluate the safety, efficacy and pharmacokinetic (PK) profile of HL-1186 Tablet in patients with postherpetic neuralgia (PHN).
Eligibility Criteria
Inclusion Criteria: 1. Aged ≥ 18 years, of either sex. 2. Pain persists for 1 month or more after healing of skin lesions in patients with herpes zoster. 3. Participants fully understand the purpose, characteristics, methods of the trial and possible AEs, voluntarily participate in the trial and sign the ICF, or have their legal guardian sign the ICF on their behalf. Exclusion Criteria: 1. Participants with any pain other than PHN, or with other diseases that the researcher considers to potentially affect the evaluation of PHN. 2. Participants who may be allergic to the active ingredients or excipients of HL-1186 Tablet, HL-1186 Tablet placebo, pregabalin capsule or pregabalin capsule placebo, have an allergic constitution, or have a history of allergies to ≥ 3 substances. 3. Participants who have used drugs that may damage nerves (such as tumor chemotherapy drugs) after being diagnosed with PHN. 4. The baseline NRS collection begins within the 5 half-lives following the last use of the prohibited drug. 5. Participants who have previously used pregabalin with inadequate efficacy or intolerance. 6. Clinically significant abnormalities in the 12-lead electrocardiogram (ECG) during the screening period, or complicated with severe cardiopulmonary diseases, which are deemed unsuitable for inclusion by the researcher. 7. Participants with a history of malignant tumors within 2 years prior to screening. 8. Participants who have undergone major surgery within 8 weeks prior to enrollment or plan to undergo any surgery during the trial period. 9. Participants with positive human immunodeficiency virus antibody, positive syphilis serological test, positive hepatitis B virus surface antigen with hepatitis B virus DNA \> ULN, or positive hepatitis C virus antibody with hepatitis C virus RNA \> ULN. 10. Participants with a history of alcoholism or drug abuse within 2 years before screening. 11. Female participants who are pregnant, breastfeeding (within 1 year after delivery), or with a positive pregnancy test. 12. Participants deemed by the investigator to be unsuitable for participating in this trial for any reason.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07758920 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Postherpetic Neuralgia ( PHN ). 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 NCT07758920 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 NCT07758920 currently recruiting?
Yes, NCT07758920 is actively recruiting participants. Contact the research team at clinical_trial@hllife.com.cn for enrollment information.
Where is the NCT07758920 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07758920 clinical trial?
NCT07758920 is sponsored by Shanghai Yidian Pharmaceutical Technology Development Co., Ltd.. The trial plans to enroll 200 participants.