Overview
A Phase 1b Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of SR419
Status:
Recruiting
Recruiting
Trial end date:
2021-12-31
2021-12-31
Target enrollment:
0
0
Participant gender:
All
All
Summary
This study is to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of SR419 in Patients with Peripheral Neuropathic PainPhase:
Phase 1Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
SIMR (Australia) Biotech Pty Ltd
SIMR (Australia) Biotech Pty Ltd.
Criteria
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).