NCT04494815

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

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Shanghai SIMR Biotechnology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Peripheral Neuropathic Pain

Interventions

Type	Name	Description
DRUG	SR419	Each participant will receive 1 dose of 20 mg SR419 oral suspension.
DRUG	active control	Each participant will receive 1 dose of 300 mg active control capsule.
DRUG	SR419 placebo	Each participant will receive 2 doses of SR419 placebo oral suspension.
DRUG	active control placebo	Each participant will receive 2 doses of active control placebo capsule.

Timeline

• Start date: 2020-09-18
• Primary completion: 2022-05-31
• Completion: 2022-07-31
• First posted: 2020-07-31
• Last updated: 2025-08-13

Locations

1 site across 1 country: Australia