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RecruitingNCT07758920Updated Aug 11, 2026

A Clinical Trial to Evaluate the Efficacy and Safety of HL-1186 Tablet in the Treatment of Postherpetic Neuralgia

A Phase 2 interventional study of HL-1186 and HL-1186 placebo in Postherpetic Neuralgia ( PHN ), sponsored by Shanghai Yidian Pharmaceutical Technology Development Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-11.

Sponsored by Shanghai Yidian Pharmaceutical Technology Development Co., Ltd. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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).

02

Conditions studied

  • Postherpetic Neuralgia ( PHN )
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    HL-1186 High Dose

    Participants will receive continuous HL-1186 administration for 12 weeks

    Drug: HL-1186 · Drug: Pregabalin capsule placebo

  • Experimental
    HL-1186 Medium Dose

    Participants will receive continuous HL-1186 administration for 12 weeks

    Drug: HL-1186 · Drug: HL-1186 placebo · Drug: Pregabalin capsule placebo

  • Experimental
    HL-1186 Low Dose

    Participants will receive continuous HL-1186 administration for 12 weeks

    Drug: HL-1186 · Drug: HL-1186 placebo · Drug: Pregabalin capsule placebo

  • Active comparator
    Pregabalin

    Participants will receive continuous Pregabalin administration for 12 weeks

    Drug: HL-1186 placebo · Drug: Pregabalin capsule

  • Placebo comparator
    Placebo

    Participants will receive continuous placebo administration for 12 weeks

    Drug: HL-1186 placebo · Drug: Pregabalin capsule placebo

Interventions

  • DrugHL-1186

    HL-1186 tablet for oral administration

  • DrugHL-1186 placebo

    HL-1186 placebo tablet for oral administration

  • DrugPregabalin capsule

    Pregabalin capsule for oral administration

  • DrugPregabalin capsule placebo

    Pregabalin capsule placebo for oral administration

05

What researchers measure

Primary outcomes

  1. Change in the Average Daily Pain Score (ADPS) from baseline after 12 weeks of administration

    ADPS = sum of NRS scores within 7 days / number of times the form is filled out NRS (Numeric Rating Scale, 0 =no pain to 10 =worst possible pain)

    Time frame: Day 1 to Day 84

Secondary outcomes

  1. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

    Time frame: Day 1 to Day 98

06

Study locations

1 of 1 sites recruiting
  • Peking University First Hospital
    Beijing, China
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07758920
Lead sponsor
Shanghai Yidian Pharmaceutical Technology Development Co., Ltd.
Responsible party
Sponsor
First posted
Aug 11, 2026
Start date
Aug 2026 (estimated)
Primary completion
Jun 2027 (estimated)
Completion
Jun 2027 (estimated)
Last update
Aug 11, 2026

Study contacts

Renhai Yang
Contact
clinical_trial@hllife.com.cn
021-64311017

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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