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Placebo of YJ001 for Spray Use for Diabetic Neuropathy

Phase 1

Waitlist Available

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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 1year

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Safety Assessments - AEs

Safety Assessments - Skin Reaction

Safety Assessments -Number of Participants With Abnormal Laboratory Values

Secondary outcome measures

Efficacy evaluation indicator

Efficacy evaluation indicators - ADSIS

Efficacy evaluation indicators - SF-MPQ

+7 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

Placebo of YJ001 for Spray Use

2022

Completed Phase 1

~40

YJ001 for Spray Use

2022

Completed Phase 1

~40

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Zhejiang Hanmai Pharmaceutical Technology Co., Ltd.Lead Sponsor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the risks associated with using YJ001 as a spray treatment for individuals?

"YJ001 for Spray Use is currently undergoing a Phase 1 trial where the safety rating has been assessed as 1 by our team at Power, indicating that there is scarce supportive data regarding its safety and efficacy."

Answered by AI

Is the enrollment process open for this medical study at present?

"As per clinicaltrials.gov, the medical trial is not presently enrolling participants. Initially listed on April 10th, 2024, with the latest update made on April 8th, 2024. However, it's worth noting that while this specific study isn't actively seeking patients currently, there are a total of 178 other trials open for enrollment at present."

Answered by AI

Is the study open to individuals who have surpassed 25 years of age?

"The eligibility criteria for this research project stipulates that eligible candidates must fall within the age range of 18 to 80 years old. It is worth noting that there are a total of 9 investigations dedicated to individuals under 18 and 163 pertaining to those above 65 years old."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Multiple-Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of YJ001 for Spray Use in Patients With Diabetic Peripheral Neuropathic Pain

2024. "Multiple-Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of YJ001 for Spray Use in Patients With Diabetic Peripheral Neuropathic Pain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06361108.

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