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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai Yidian Pharmaceutical Technology Development Co., Ltd.

About this trial

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

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • HL-1186
  • HL-1186 placebo
  • Pregabalin capsule
  • Pregabalin capsule placebo

Treatment groups

200 Participants
are divided into 5 treatment groups