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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

In context

Neuralgia, Postherpetic

196 studies on the registry are indexed under Neuralgia, Postherpetic; 28 are open to participants now.

This study's planned enrollment of 200 is above the median of 94 across 162 interventional studies indexed under Neuralgia, Postherpetic.

Browse Neuralgia, Postherpetic studies →

Lead sponsor

Shanghai Yidian Pharmaceutical Technology Development Co., Ltd. is the lead sponsor of 9 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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. abnormalities in the 12-lead (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 antibody, positive syphilis serological test, positive virus surface antigen with hepatitis B virus DNA > , or positive 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.
Terms in these criteria, in plain language(7)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

05

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

  • HL-1186 tablet for oral administration

  • DrugHL-1186 placebo

    HL-1186 placebo tablet for oral administration

  • Pregabalin capsule for oral administration

  • DrugPregabalin capsule placebo

    Pregabalin capsule placebo for oral administration

06

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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Aug 2026; primary completion for Jun 2027, 10 months later.

Of 12 phase 2 interventional studies under Neuralgia, Postherpetic, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 17. This study's planned 10 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 2, 2026
First posted
Aug 11, 2026
StartEst.
Aug 2026
Primary completionEst.
Jun 2027
CompletionEst.
Jun 2027
Last update
Aug 11, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

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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