Peripheral Neuropathic Pain
Conditions
Keywords
DPN, PHN...etc.
Brief summary
This study is to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of SR419 in Patients with Peripheral Neuropathic Pain
Detailed description
This is a three-period, complete crossover, double-blind, randomised, placebo- and active-controlled study to compare the preliminary efficacy of a single dose of SR419 to placebo and active control in patients with peripheral neuropathic pain. The study also aims to evaluate the safety, tolerability, and PK of single doses of SR419 in patients with peripheral neuropathic pain.
Interventions
DRUGSR419
Each participant will receive 1 dose of 20 mg SR419 oral suspension.
DRUGactive control
Each participant will receive 1 dose of 300 mg active control capsule.
DRUGSR419 placebo
Each participant will receive 2 doses of SR419 placebo oral suspension.
Each participant will receive 2 doses of active control placebo capsule.
Sponsors
Shanghai SIMR Biotechnology Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Aged ≥18 years at the time of informed consent. 2. Be diagnosed as suffering from chronic peripheral neuropathic pain, and specifically PHN or DPN. 3. Average daily pain over the last week prior to Screening to be of at least moderate severity (a score of ≥4 on the 11-point numeric rating scale \[NRS\]) and be of face, limb or torso location. 4. A minimum score of 19 on the pain DETECT questionnaire.
Exclusion criteria
1. Being pregnant or lactating at Screening or planning to become pregnant (self or partner) at any time during the study. 2. Prior or ongoing medical conditions, medical history, physical findings, or laboratory abnormality. 3. Known or suspected intolerance or hypersensitivity to any of the study drugs, close related compounds, or any of the stated ingredients. 4. Participants on controlled-release opioids (e.g., morphine) unless on a stable dose of Morphine Equivalent Dose (assessed by the Faculty of Pain Medicine Opioids Calculator) of up to and including 60 mg/day, at the discretion of the Investigator. Participants on instant-release opioids (e.g., codeine, oxycodone) must withhold dosing for 12 hours prior to administration of study drug. 5. Positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV). 6. Creatinine clearance as estimated by estimated glomerular filtration rate (eGFR) \<60 mL/min. 7. A history of major psychiatric disorder(s).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| QST of an affected area. | Up to Day18(-2~+5) for the safety follow up since Day1 | QST: Quantitative sensory testing |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The incidence, frequency, and severity of TEAEs. | Up to Day18(-2~+5) for the safety follow up since Day1 | TEAE: Treatment-Emergent Adverse Events |
| Spontaneous pain score | Up to Day18(-2~+5) for the safety follow up since Day1 | Pain score will be assessed via painDETECT questionnaire with a value range of 0\ 38, which includes three situations: If a subject gets a score of 0\ 12, it means a neuropathic pain component is unlikely(less than 15% probability); if a score of 13\ 19, it means the result is ambiguous, however, a neuropathic pain component can be present; if the score is equal to or greater than nineteen, it means a neuropathic pain is likely(more than 90% probability). |
| QST of an unaffected area. | Up to Day18(-2~+5) for the safety follow up since Day1 | — |
| Plasma concentration of SR419 after dosing. | Up to Day11(+3) | — |
Countries
Australia
Outcome results
None listed