NCT07859111|RecruitingPhase 3

YJ001 Spray for Diabetic Peripheral Neuropathic Pain

Multicenter, Randomized, Double-blind, Double Simulation, Positive Drug and Placebo Parallel Control Phase III Clinical Trial And Open-label Extension Trial of YJ001 for Spray Use the Treatment of Diabetic Peripheral Neuropathic Pain

Zhejiang Hanmai Pharmaceutical Technology Co., Ltd.ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

BOJI2025014ZYS

Study Type

interventional

Estimated enrollment

400

Locations

1 country

Sites

Timeline

Study Start

August 3, 2026

Actual (reported)

Primary Completion

August 30, 2028

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Study Completion

August 30, 2028

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Brief 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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: recruiting
Estimated enrollment: 400 participants
Study completion date: August 30, 2028
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.
Listed locations: 1 countries · 1 sites

Trial Relationships

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Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
August 3, 2026
Actual (reported)
First Submitted
September 20, 2026
Actual (reported)
First Posted
October 5, 2026
Actual (reported)
Primary Completion
August 30, 2028
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
August 30, 2028
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.

Last Updated: October 5, 2026
Status Verified: September 2026
Last Update Submitted: September 29, 2026

Conditions

Diabetic Peripheral Neuropathic Pain (DPNP)

Outcome Measures

Primary Outcomes (2)

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Aged ≥18 years, of either gender
Diagnosed with type 1 or type 2 diabetes for at least 1 year
Diagnosed with diabetic peripheral neuropathic pain (DPNP, other tertiary hospitals' diagnostic certificates are acceptable), with pain duration ≥6 months, and the most painful area being the foot
Stable blood glucose control within 3 months prior to screening, i.e., glycated hemoglobin (HbA1c) ≤9.0% at screening. If the patient has been receiving hypoglycemic drug treatment at screening, stable treatment for at least 30 days is required;
If the patient has been receiving neurotrophic, circulation-improving, and metabolic drug treatments at screening, stable dosing for at least 30 days is required. If the patient has discontinued neurotrophic, circulation-improving, and metabolic drug treatments at screening, the duration of drug withdrawal must meet at least 7 drug half-lives as determined by the investigator;
If the patient has been receiving non-pharmacological treatments (including physiotherapy, massage, chiropractic treatment, psychological therapy, etc.) at screening, stable treatment for at least 12 weeks is required, and the treatment regimen must not be changed during the trial
If the patient has not been receiving stable non-pharmacological treatments (including physiotherapy, massage, chiropractic treatment, psychological therapy, etc.), non-pharmacological treatment must be discontinued for at least 1 week prior to screening, and no additional non-pharmacological treatments are planned to be added during the trial
Pain NRS score ≥4.0 and \<9.0 at screening

You may not qualify if:

The ADPS score during the run-in period \[defined as the average of the daily pain NRS scores calculated based on the patient diary card records excluding the day of randomization\] is ≥4, and the trial participant completes at least 10 pain assessments during the run-in period (excluding the day of randomization); - Both pain VAS scores at screening and during the 2-day visit before randomization are ≥40mm and \<90mm
Medication adherence to the study drug during the run-in period is 80-120% (inclusive)
The trial participant is willing and able to adhere to study visit schedules, treatment plans, laboratory tests, and other research procedures, agrees to participate in this trial, and signs a written informed consent form.
Participants in the second part of the trial must meet all the following criteria to be eligible for enrollment in the second part of this study.

Contact the study team to confirm eligibility.

YJ001 Spray for Diabetic Peripheral Neuropathic Pain

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (18)

Study Arms (3)

Placebo group

experimental group

positive control group

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Central Study Contacts

Study Design

Study Record Dates

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (18)

Study Arms (3)

Placebo group

experimental group

positive control group

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Central Study Contacts

Study Design

Study Record Dates

Source record

Locations