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Peripheral Neuropathic PainPhase 1/2NCT04494815

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

A Phase 1/2 study testing SR419 in people with Peripheral Neuropathic Pain, run by Shanghai SIMR Biotechnology Co., Ltd. at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Peripheral Neuropathic Pain
What is being tested?
SR419
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
24 participants
Where
1 siteAustralia
Study dates
18 Sep 2020to 31 Jul 2022
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country.

Australia1 site

  • Clinical Research Facility Medical School, University of Adelaide

    Adelaide, South Australia, 5000

Other trials in Australia

About this study

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

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

Read the 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.

Being tested
SR419, active control, SR419 placebo, active control placebo
Keywords
DPN, PHN...etc.

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SR419Drug

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

  • active controlDrug

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

  • SR419 placeboDrug

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

  • active control placeboDrug

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

Study groups in NCT04494815
Study groupRoleWhat they receive
Treatment AExperimentalTreatment A: Single 20 mg oral suspension dose of SR419 + single active control placebo capsule.
Receives: Drug: SR419; Drug: active control placebo
Treatment BActive comparatorTreatment B: Single SR419 placebo oral suspension + single 300 mg oral capsule of active control.
Receives: Drug: active control; Drug: SR419 placebo
Treatment CPlacebo comparatorTreatment C: Single SR419 placebo oral suspension + single active control placebo capsule.
Receives: Drug: active control; Drug: active control placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. QST of an affected area.

    QST: Quantitative sensory testing

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

Secondary outcomes (4)

  1. The incidence, frequency, and severity of TEAEs.

    TEAE: Treatment-Emergent Adverse Events

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

  2. 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).

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

  3. QST of an unaffected area.

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

  4. Plasma concentration of SR419 after dosing.

    Measured: Up to Day11(+3)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jul 2020
  2. Study start18 Sep 2020
  3. Primary completion31 May 2022
  4. Study completion31 Jul 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04494815
Sponsor's protocol ID
SR419-102
Status last verified
Nov 2024
First submitted
28 Jul 2020
Last updated
13 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing SR419 in people with Peripheral Neuropathic Pain, run by Shanghai SIMR Biotechnology Co., Ltd. at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

QST of an affected area. (time frame: Up to Day18(-2~+5) for the safety follow up since Day1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04494815.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2025.

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