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

Phase 1

Completed

• Conditions: Peripheral Neuropathic Pain
• Interventions: Drug: SR419; Drug: active control; Drug: active control placebo; Drug: SR419 placebo

• Registration Number: NCT04494815
• Lead Sponsor: Shanghai SIMR Biotechnology Co., Ltd.

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 single center, 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 Timeline

• Study First Submitted: 2020-07-28
• Study First Submitted QC: 2020-07-28
• Study First Posted: 2020-07-31
• Study Start: 2020-09-18
• Primary Completion: 2022-05-31
• Study Completion: 2022-07-31
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-26
• Last Update Posted: 2024-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment A	SR419	Treatment A: Single 20 mg oral suspension dose of SR419 + single active control placebo capsule.
Treatment A	active control placebo	Treatment A: Single 20 mg oral suspension dose of SR419 + single active control placebo capsule.
Treatment B	SR419 placebo	Treatment B: Single SR419 placebo oral suspension + single 300 mg oral capsule of active control.
Treatment C	active control	Treatment C: Single SR419 placebo oral suspension + single active control placebo capsule.
Treatment B	active control	Treatment B: Single SR419 placebo oral suspension + single 300 mg oral capsule of active control.
Treatment C	active control placebo	Treatment C: Single SR419 placebo oral suspension + single active control placebo capsule.

Primary Outcome Measures

Name	Time	Method
QST of an affected area.	Up to Day18(-2~+5) for the safety follow up since Day1	QST: Quantitative sensory testing

Secondary Outcome Measures

Name	Time	Method
QST of an unaffected area.	Up to Day18(-2~+5) for the safety follow up since Day1
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).
Plasma concentration of SR419 after dosing.	Up to Day11(+3)

Trial Locations

Locations (1)

Clinical Research Facility Medical School, University of Adelaide; 🇦🇺 Adelaide, South Australia, Australia