A Phase 1b Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of SR419

Shanghai SIMR Biotechnology Co., Ltd.24 enrolled

Overview

This study is to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of SR419 in Patients with Peripheral Neuropathic Pain

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Peripheral Neuropathic Pain

Interventions

SR419DRUG

Each participant will receive 1 dose of 20 mg SR419 oral suspension.

active controlDRUG

Each participant will receive 1 dose of 300 mg active control capsule.

SR419 placeboDRUG

Each participant will receive 2 doses of SR419 placebo oral suspension.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Locations (1)

Clinical Research Facility Medical School, University of Adelaide

Adelaide, South Australia, Australia

Outcomes

Primary Outcomes

QST of an affected area.

QST: Quantitative sensory testing

Time frame: Up to Day18(-2~+5) for the safety follow up since Day1

Secondary Outcomes

The incidence, frequency, and severity of TEAEs.

TEAE: Treatment-Emergent Adverse Events

Time frame: Up to Day18(-2~+5) for the safety follow up since Day1

Spontaneous pain score

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).

Time frame: Up to Day18(-2~+5) for the safety follow up since Day1

QST of an unaffected area.

Time frame: Up to Day18(-2~+5) for the safety follow up since Day1

Plasma concentration of SR419 after dosing.

Time frame: Up to Day11(+3)

Data from ClinicalTrials.gov

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