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

Peripheral Neuropathic Pain Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04494815
• Other study ID #: SR419-102
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: September 18, 2020
• Est. completion date: July 31, 2022

Study information

• Verified date: August 2022
• Source: Shanghai SIMR Biotechnology Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: July 31, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Neuralgia
• Peripheral Neuropathic Pain

Intervention

Drug:
• SR419
Each participant will receive 1 dose of 20 mg SR419 oral suspension.
• active control
Each participant will receive 1 dose of 300 mg active control capsule.
• SR419 placebo
Each participant will receive 2 doses of SR419 placebo oral suspension.
• active control placebo
Each participant will receive 2 doses of active control placebo capsule.

Locations

Country	Name	City	State
Australia	Clinical Research Facility Medical School, University of Adelaide	Adelaide	South Australia

Sponsors (1)

Lead Sponsor	Collaborator
SIMR (Australia) Biotech Pty Ltd.

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	QST of an affected area.	QST: Quantitative sensory testing	Up to Day18(-2~+5) for the safety follow up since Day1
Secondary	The incidence, frequency, and severity of TEAEs.	TEAE: Treatment-Emergent Adverse Events	Up to Day18(-2~+5) for the safety follow up since Day1
Secondary	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).	Up to Day18(-2~+5) for the safety follow up since Day1
Secondary	QST of an unaffected area.		Up to Day18(-2~+5) for the safety follow up since Day1
Secondary	Plasma concentration of SR419 after dosing.		Up to Day11(+3)