- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04494815
A Phase 1b Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of SR419
August 2, 2022 updated by: SIMR (Australia) Biotech Pty Ltd.
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
This study is to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of SR419 in Patients with Peripheral Neuropathic Pain
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
24
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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South Australia
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Adelaide, South Australia, Australia, 5000
- Clinical Research Facility Medical School, University of Adelaide
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment A
Treatment A: Single 20 mg oral suspension dose of SR419 + single active control placebo capsule.
|
Each participant will receive 1 dose of 20 mg SR419 oral suspension.
Each participant will receive 2 doses of active control placebo capsule.
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Active Comparator: Treatment B
Treatment B: Single SR419 placebo oral suspension + single 300 mg oral capsule of active control.
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Each participant will receive 1 dose of 300 mg active control capsule.
Each participant will receive 2 doses of SR419 placebo oral suspension.
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Placebo Comparator: Treatment C
Treatment C: Single SR419 placebo oral suspension + single active control placebo capsule.
|
Each participant will receive 2 doses of active control placebo capsule.
Each participant will receive 1 dose of 300 mg active control capsule.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
QST of an affected area.
Time Frame: Up to Day18(-2~+5) for the safety follow up since Day1
|
QST: Quantitative sensory testing
|
Up to Day18(-2~+5) for the safety follow up since Day1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Up to Day18(-2~+5) for the safety follow up since Day1
|
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).
|
Up to Day18(-2~+5) for the safety follow up since Day1
|
QST of an unaffected area.
Time Frame: Up to Day18(-2~+5) for the safety follow up since Day1
|
Up to Day18(-2~+5) for the safety follow up since Day1
|
|
Plasma concentration of SR419 after dosing.
Time Frame: Up to Day11(+3)
|
Up to Day11(+3)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Kai Wu, SIMR
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 18, 2020
Primary Completion (Actual)
May 31, 2022
Study Completion (Actual)
July 31, 2022
Study Registration Dates
First Submitted
July 28, 2020
First Submitted That Met QC Criteria
July 28, 2020
First Posted (Actual)
July 31, 2020
Study Record Updates
Last Update Posted (Actual)
August 5, 2022
Last Update Submitted That Met QC Criteria
August 2, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SR419-102
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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