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

NCT04494815 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-08-13

No results posted yet for this study

Summary

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

Conditions

  • Peripheral Neuropathic Pain

Interventions

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.

Sponsors & Collaborators

  • Shanghai SIMR Biotechnology Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Kai Wu · SIMR

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-18
Primary Completion
2022-05-31
Completion
2022-07-31

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04494815 on ClinicalTrials.gov