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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04494815




Registration number
NCT04494815
Ethics application status
Date submitted
28/07/2020
Date registered
31/07/2020
Date last updated
3/12/2020

Titles & IDs
Public title
A Phase 1b Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of SR419
Scientific 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
Secondary ID [1] 0 0
SR419-102
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peripheral Neuropathic Pain 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - SR419
Treatment: Drugs - active control
Treatment: Drugs - SR419 placebo
Treatment: Drugs - active control placebo

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

Experimental: Treatment A+Treatment C+Treatment B -

Experimental: Treatment B+Treatment A+Treatment C -

Experimental: Treatment B+Treatment C+Treatment A -

Experimental: Treatment C+Treatment A+Treatment B -

Experimental: Treatment C+Treatment B+Treatment A -


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

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

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

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

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
QST of an affected area. - QST: Quantitative sensory testing
Timepoint [1] 0 0
Up to Day18(-2~+5) for the safety follow up since Day1
Secondary outcome [1] 0 0
The incidence, frequency, and severity of TEAEs. - TEAE: Treatment-Emergent Adverse Events
Timepoint [1] 0 0
Up to Day18(-2~+5) for the safety follow up since Day1
Secondary outcome [2] 0 0
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).
Timepoint [2] 0 0
Up to Day18(-2~+5) for the safety follow up since Day1
Secondary outcome [3] 0 0
QST of an unaffected area.
Timepoint [3] 0 0
Up to Day18(-2~+5) for the safety follow up since Day1
Secondary outcome [4] 0 0
Plasma concentration of SR419 after dosing.
Timepoint [4] 0 0
Up to Day11(+3)

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Clinical Research Facility Medical School, University of Adelaide - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
SIMR (Australia) Biotech Pty Ltd
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study is to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of SR419
in Patients with Peripheral Neuropathic Pain
Trial website
https://clinicaltrials.gov/show/NCT04494815
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Kai Wu
Address 0 0
SIMR
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Tina Zhao
Address 0 0
Country 0 0
Phone 0 0
+86 021 61161537
Fax 0 0
Email 0 0
contact@simrbio.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04494815