Overview

To Evaluate the Efficacy and Safety of SR419 in Patients With Postherpetic Neuralgia (PHN)

Status:
Not yet recruiting
Trial end date:
2023-07-31
Target enrollment:
0
Participant gender:
All
Summary
This is a Phase II, international multicenter, double-blind, placebo-controlled, crossover study to assess the efficacy of SR419 in PHN subjects.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Shanghai SIMR Biotechnology Co., Ltd.
Criteria
Inclusion Criteria:

1. Adult male or female over 18 years old;

2. Having neuropathic pain of postherpetic neuralgia (PHN) that persists for >3 months
after the herpes zoster rash is healed, with the pain area of a continuous area of
affected rash.

3. DN4 score is ≥4 at Screening;

4. Average PI-NRS score of PHN-associated neuropathic pain over the last 24 hours at
Screening is ≥4 and ≤9;

5. Female subjects must be non-pregnant and non-lactating;

Exclusion Criteria:

1. Other pains that cannot be clearly differentiated from PHN and may interfere with PHN
assessment;

2. Circumstances that may affect pain assessment as determined by the investigator, such
as skin disorders in the affected skin area that may affect sensation;

3. Active herpes zoster infection at screening;

4. Serious acute or chronic medical condition that, as assessed by the investigator,
could increase the risks in subjects for participating in the trial or taking the
study drug, or interfere with the study results;

5. Previous administration of other study drugs within 30 days or 5 half-lives before the
study intervention used in this study (whichever is longer).