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

NCT04494815 | Completed Phase 1

• 1 other identifier: SR419-102
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Peripheral Neuropathic Pain

Keywords

DPN, PHN...etc.

Outcome Measures

Primary Outcomes (1)

• QST of an affected area.

  QST: Quantitative sensory testing

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

Secondary Outcomes (4)

• The incidence, frequency, and severity of TEAEs.

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

• Spontaneous pain score

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

• 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)

Study Arms (3)

Treatment A

EXPERIMENTAL

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

Drug: SR419; Drug: active control placebo

Treatment B

ACTIVE COMPARATOR

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

Drug: active control; Drug: SR419 placebo

Treatment C

PLACEBO COMPARATOR

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

Drug: active control; Drug: active control placebo

Interventions

SR419 DRUG

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

Treatment A

active control DRUG

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

Treatment B; Treatment C

SR419 placebo DRUG

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

Treatment B

active control placebo DRUG

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

Treatment A; Treatment C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Shanghai SIMR Biotechnology Co., Ltd.: lead

Study Sites (1)

Clinical Research Facility Medical School, University of Adelaide

Adelaide, South Australia, 5000, Australia

Location

Study Officials

• Kai Wu

  SIMR

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2020
• First Posted: July 31, 2020
• Study Start: September 18, 2020
• Primary Completion: May 31, 2022
• Study Completion: July 31, 2022
• Last Updated: August 13, 2025

Record last verified: 2024-11

Locations

AU (1)