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Completed

NCT Number: NCT04494815

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

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

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Key information

Conditions

Peripheral Neuropathic Pain

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Clinical Research Facility Medical School, University of Adelaide

Adelaide, South Australia, 5000, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged ≥18 years at the time of informed consent.
  • Be diagnosed as suffering from chronic peripheral neuropathic pain, and specifically PHN or DPN.
  • 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.
  • A minimum score of 19 on the pain DETECT questionnaire.

Exclusion criteria

  • Being pregnant or lactating at Screening or planning to become pregnant (self or partner) at any time during the study.
  • Prior or ongoing medical conditions, medical history, physical findings, or laboratory abnormality.
  • Known or suspected intolerance or hypersensitivity to any of the study drugs, close related compounds, or any of the stated ingredients.
  • 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.
  • Positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV).
  • Creatinine clearance as estimated by estimated glomerular filtration rate (eGFR) <60 mL/min.
  • A history of major psychiatric disorder(s).

Treatment and study plan

SR419

Drug

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

Active Control

Drug

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

SR419 placebo

Drug

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

Active Control Placebo

Drug

Each participant will receive 2 doses of active control placebo capsule.

Primary outcomes

  1. QST of an affected area.

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

    QST: Quantitative sensory testing

Secondary outcomes

  1. The incidence, frequency, and severity of TEAEs.

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

    TEAE: Treatment-Emergent Adverse Events

  2. Spontaneous pain score

    Time frame: 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).

  3. QST of an unaffected area.

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

  4. Plasma concentration of SR419 after dosing.

    Time frame: Up to Day11(+3)

Sponsors and collaborators

Lead sponsor

Shanghai SIMR Biotechnology Co., Ltd.

Industry

Registry information

Official study title

A Phase 1b, Randomised, Double-blind, Placebo- and Active Controlled, Single Dose Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of SR419 in Patients With Peripheral Neuropathic Pain

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jul 31, 2020
Registry last updated
Aug 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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