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

NCT07758920 | Recruiting Phase 2

• 1 other identifier: PY-HL-1186-PHN-304
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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).

Conditions

Postherpetic Neuralgia ( PHN )

Outcome Measures

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)

  Day 1 to Day 84

Secondary Outcomes (1)

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

  Day 1 to Day 98

Study Arms (5)

HL-1186 High Dose

EXPERIMENTAL

Participants will receive continuous HL-1186 administration for 12 weeks

Drug: HL-1186; Drug: Pregabalin capsule placebo

HL-1186 Medium Dose

EXPERIMENTAL

Participants will receive continuous HL-1186 administration for 12 weeks

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

HL-1186 Low Dose

EXPERIMENTAL

Participants will receive continuous HL-1186 administration for 12 weeks

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

Pregabalin

ACTIVE COMPARATOR

Participants will receive continuous Pregabalin administration for 12 weeks

Drug: HL-1186 placebo; Drug: Pregabalin capsule

Placebo

PLACEBO COMPARATOR

Participants will receive continuous placebo administration for 12 weeks

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

Interventions

HL-1186 DRUG

HL-1186 tablet for oral administration

HL-1186 High Dose; HL-1186 Low Dose; HL-1186 Medium Dose

HL-1186 placebo DRUG

HL-1186 placebo tablet for oral administration

HL-1186 Low Dose; HL-1186 Medium Dose; Placebo; Pregabalin

Pregabalin capsule DRUG

Pregabalin capsule for oral administration

Pregabalin

Pregabalin capsule placebo DRUG

Pregabalin capsule placebo for oral administration

HL-1186 High Dose; HL-1186 Low Dose; HL-1186 Medium Dose; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged ≥ 18 years, of either sex.
• Pain persists for 1 month or more after healing of skin lesions in patients with herpes zoster.
• 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.

You may not qualify if:

• Participants with any pain other than PHN, or with other diseases that the researcher considers to potentially affect the evaluation of PHN.
• 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.
• Participants who have used drugs that may damage nerves (such as tumor chemotherapy drugs) after being diagnosed with PHN.
• The baseline NRS collection begins within the 5 half-lives following the last use of the prohibited drug.
• Participants who have previously used pregabalin with inadequate efficacy or intolerance.
• Participants with a history of malignant tumors within 2 years prior to screening.
• Participants who have undergone major surgery within 8 weeks prior to enrollment or plan to undergo any surgery during the trial period.
• 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.
• Participants with a history of alcoholism or drug abuse within 2 years before screening.
• Female participants who are pregnant, breastfeeding (within 1 year after delivery), or with a positive pregnancy test.
• Participants deemed by the investigator to be unsuitable for participating in this trial for any reason.

Sponsors & Collaborators

• Shanghai Yidian Pharmaceutical Technology Development Co., Ltd.: lead

Study Sites (1)

Peking University First Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Neuralgia, Postherpetic

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Neuralgia; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Central Study Contacts

Renhai Yang

CONTACT

021-64311017; clinical_trial@hllife.com.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2026
• First Posted: August 11, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: August 11, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)