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

NCT ID: NCT04494815

Last Updated: 2025-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-18
• Study Completion Date: 2022-07-31

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.

Conditions

Peripheral Neuropathic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Treatment A

Treatment A: Single 20 mg oral suspension dose of SR419 + single active control placebo capsule.

Group Type: EXPERIMENTAL

SR419

Intervention Type: DRUG

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

active control placebo

Intervention Type: DRUG

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

Treatment B

Treatment B: Single SR419 placebo oral suspension + single 300 mg oral capsule of active control.

Group Type: ACTIVE_COMPARATOR

active control

Intervention Type: DRUG

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

SR419 placebo

Intervention Type: DRUG

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

Treatment C

Treatment C: Single SR419 placebo oral suspension + single active control placebo capsule.

Group Type: PLACEBO_COMPARATOR

active control

Intervention Type: DRUG

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

active control placebo

Intervention Type: DRUG

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

Interventions

SR419

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

Intervention Type: DRUG

active control

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

Intervention Type: DRUG

SR419 placebo

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

Intervention Type: DRUG

active control placebo

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

Intervention Type: DRUG

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai SIMR Biotechnology Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kai Wu

Role: STUDY_DIRECTOR

SIMR

Locations

Clinical Research Facility Medical School, University of Adelaide

Adelaide, South Australia, Australia

Countries

Australia

Other Identifiers

SR419-102

Identifier Type: -

Identifier Source: org_study_id