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YJ001 Spray for Diabetic Neuropathy

Phase 1
Recruiting
Led By Douglas Scott Denham
Research Sponsored by Zhejiang Hanmai Pharmaceutical Technology Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1year

Summary

This trial will test the safety and effectiveness of a new medication, YJ001, for diabetic peripheral neuropathy pain. The study will involve two groups of patients who will receive either the medication or a

Who is the study for?
This trial is for individuals with diabetic peripheral neuropathic pain (DPNP). Participants should be able to apply a spray treatment on their feet and follow the study's schedule. Specific eligibility details are not provided, but typically include factors like age range, severity of DPNP, and overall health status.
What is being tested?
The trial is testing YJ001, a new medication in spray form against a placebo spray. It's designed to see if it's safe and works for relieving nerve pain in diabetic patients. The test involves multiple doses over several days at one study center with both men and women participating equally.
What are the potential side effects?
Since this is an early-phase trial focusing on safety and tolerability, specific side effects of YJ001 are not listed but may include reactions at the site of application or systemic effects related to its pharmacological action.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Safety Assessments - AEs
Safety Assessments - Skin Reaction
Safety Assessments -Number of Participants With Abnormal Laboratory Values
Secondary study objectives
Efficacy evaluation indicator
Efficacy evaluation indicators
Pharmacokinetics - CLr/f,ss
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Cohort M2 (10 active, 2 placebo)Experimental Treatment2 Interventions
414 mg/administration
Group II: Cohort M1 (10active, 2 placebo)Experimental Treatment2 Interventions
296 mg/administration
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
YJ001 for Spray Use
2022
Completed Phase 1
~40
Placebo of YJ001 for Spray Use
2022
Completed Phase 1
~40

Find a Location

Who is running the clinical trial?

Zhejiang Hanmai Pharmaceutical Technology Co., Ltd.Lead Sponsor
Douglas Scott DenhamPrincipal Investigator5430 Fredericksburg Rd, Suite 200, San Antonio Texas 78229
~10 spots leftby Mar 2025
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