YJ001 Spray for Diabetic Peripheral Neuropathic Pain

Summary

The goal of this clinical trial is to learn if YJ001 Spray works to treat diabetic patients with Diabetic Peripheral Neuropathic Pain..It will also learn about the safety of drug YJ001 Spray.This trial is divided into two parts. The first part of the trial is designed as a randomized, double-blind, double-dummy, parallel-controlled, multi-center clinical trial with positive reference product and placebo; the second part is designed as a single-arm, open-label, multi-center clinical trial.In the first part, the trial was divided into the test group, the positive control group, and the placebo group. In the first part,The experimental group received YJ001 spray + clobazam besylate capsule placebo, the positive control group received YJ001 spray placebo + clobazam besylate capsule, and the placebo group received YJ001 spray placebo + clobazam besylate capsule placebo. In the second part, all participants were treated with the investigational product, and 30 trial participants underwent PK blood sample collection according to the protocol. Part I of the trial : To evaluate the efficacy and safety of YJ001 spray in treating diabetic peripheral neuropathic pain. Part 2 of the trial: Evaluate the long-term efficacy and the pharmacokinetic characteristics of YJ001 spray in treating dia betic peripheral neuropathic pain at the clinically recommended dosage. Participants will: Apply spray topically to both feet twice daily, with six sprays per foot at each administration. Visit the clinic once every 1 or 2 or 4 weeks for checkups and tests Complete a study diary daily to record pain intensity, sleep interference, study-drug administration, and spray-related respiratory irritation.

Timeline

Start

2026-08-03

Primary completion

2028-08-30

Completion

2028-08-30

Drugs

Indications