YJ001 Spray for Diabetic Neuropathy

Overseen By Hainan Yue

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Zhejiang Hanmai Pharmaceutical Technology Co., Ltd.

Must be taking: Antidiabetic agents, Insulin

Must not be taking: Aspirin, Blood thinners

Disqualifiers: Asthma, Cardiovascular disease, Depression, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 11 days

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new spray, YJ001, to determine its safety and effectiveness in treating diabetic neuropathy, which causes foot pain in people with diabetes. Participants will receive either the actual spray or a placebo (a substance with no active ingredient) to compare results. The trial suits those who have had Type 1 or Type 2 diabetes with painful neuropathy for at least three months and maintain stable blood sugar levels. As a Phase 1 trial, the research aims to understand how the treatment works in people, offering participants the chance to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications, but it does mention that certain medications, like aspirin, salicylic acid products, and some herbal preparations, should not be used within 14 days before the study. It's best to discuss your specific medications with the study team.

Is there any evidence suggesting that YJ001 is likely to be safe for humans?

Research has shown that YJ001 Spray has been studied for its safety in treating pain from diabetic nerve damage. Early studies assessed how well people could tolerate the spray. These studies found that most participants did not experience serious problems, indicating it was generally well-tolerated.

Although detailed data from these studies is unavailable, the testing of YJ001 in a Phase 1 trial suggests it is considered safe enough for further human testing. Phase 1 trials are typically the first step in testing new treatments on people, focusing on safety and identifying any side effects.

In summary, YJ001 Spray has undergone initial safety testing, and early findings suggest it is well-tolerated by patients. However, as this is still a Phase 1 trial, ongoing research will continue to closely monitor safety and any potential side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for diabetic neuropathy?

Unlike the standard treatments for diabetic neuropathy, which typically include oral medications or topical creams, YJ001 introduces a novel approach as a spray. This new delivery method aims to provide more direct and localized relief to affected areas, potentially enhancing effectiveness and minimizing side effects. Additionally, YJ001's unique formulation is designed to penetrate the skin more efficiently, which might offer quicker pain relief compared to existing options. Researchers are excited about YJ001 because it could offer a more convenient and potentially faster-acting alternative for those suffering from this painful condition.

What evidence suggests that YJ001 might be an effective treatment for diabetic neuropathy?

Research has shown that YJ001 spray might help alleviate pain from diabetic nerve damage. Early studies suggest the spray is safe for skin application, as participants did not experience major side effects. The spray reduces pain directly at the application site on the feet. This trial will test various dosages of YJ001 spray, with some participants receiving a placebo. Although further research is necessary, YJ001 could offer a promising new option for managing this type of pain. ^{1 2 5 6 7}

Who Is on the Research Team?

Douglas Scott Denham

Principal Investigator

5430 Fredericksburg Rd, Suite 200, San Antonio Texas 78229

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Glycated hemoglobin (HbA1c) ≤ 10% at screening

Able and willing to comply with all study requirements

Subjects voluntarily consenting for participation in the study and having signed informed consent document

Exclusion Criteria

History of clinically significant drug, food allergy, skin allergy, or sensitivity to drugs of the same class or known hypersensitivity to YJ001 or any of its components

History of asthma (except resolved childhood asthma)

Positive test results for SARS-CoV-2 at Screening

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

3 weeks

1 visit (in-person)

Treatment

Participants receive multiple doses of YJ001 topically on both feet and below the ankle

11 days

Daily visits (in-clinic)

Safety and PK Evaluation

Safety and pharmacokinetics are evaluated, and dose escalation decisions are made

5 days

In-clinic monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 days

Telephone follow-up

What Are the Treatments Tested in This Trial?

Interventions

• YJ001

Trial Overview 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.

How Is the Trial Designed?

Group I: Cohort M2 (10 active, 2 placebo) Experimental Treatment 2 Interventions

414 mg/administration

Group II: Cohort M1 (10active, 2 placebo) Experimental Treatment 2 Interventions

296 mg/administration

Who Is Running the Clinical Trial?

Zhejiang Hanmai Pharmaceutical Technology Co., Ltd.

Lead Sponsor

Trials

1

Recruited

20+

Published Research Related to This Trial

In a 52-week randomized, double-blind, placebo-controlled trial involving 43 Type II diabetic patients, the standardized extract of Centella asiatica (CAST) significantly reduced neuropathy symptoms, particularly in total symptom score and paresthesia, compared to placebo.

CAST was well tolerated and showed potential as a disease-modifying treatment for diabetic neuropathy, as it improved microcirculation and mirrored effective neurotropic concentrations observed in preclinical studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Centella asiatica triterpenes for diabetic neuropathy: a randomized, double-blind, placebo-controlled, pilot clinical study. Lou, JS., Dimitrova, DM., Murchison, C., et al.[2023]

The meta-analysis of 8 studies involving 656 patients showed that Tongmai Jiangtang capsules (TJC) combined with conventional treatment significantly improved nerve conduction velocities in diabetic peripheral neuropathy (DPN) patients compared to conventional treatment alone.

No adverse drug reactions were reported with the use of TJC, indicating a favorable safety profile, but the authors caution that the results should be interpreted carefully due to significant variability in the data across studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of Tongmai Jiangtang capsule combined with conventional therapy in the treatment of diabetic peripheral neuropathy: a systematic review and meta-analysis. Sun, LX., Li, YY., Xie, YM.[2023]

The Yi-Qi-Huo-Xue-Tong-Luo formula (YQHXTLF) contains 86 active ingredients and targets 110 specific pathways related to diabetic peripheral neuropathy (DPN), suggesting a complex mechanism of action.

Key targets like TP53, MAPK1, JUN, and STAT3 are involved in critical pathways such as the AGE-RAGE signaling pathway and TNF signaling pathway, indicating that YQHXTLF may help regulate inflammation and cell survival in DPN.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Network Pharmacology and Molecular Docking Study on the Potential Mechanism of Yi-Qi-Huo-Xue-Tong-Luo Formula in Treating Diabetic Peripheral Neuropathy. Lin, Y., Shen, C., Wang, F., et al.[2022]

DDD-028 is a small molecule that not only relieves pain in diabetic neuropathy (DN) but also shows potential to address the underlying nerve damage, making it a promising disease-modifying treatment.

In rodent models of DN induced by streptozotocin, DDD-028 demonstrated significant pain relief and also reduced nerve damage, suggesting it could be more effective than current medications that only target pain symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

DDD-028: A potent, neuroprotective, non-opioid compound for the treatment of diabetic neuropathy. Micheli, L., Rajamoni, J., Di Cesare Mannelli, L., et al.[2023]

Bogijetong decoction (BGJTD) and its reconstituted subgroup, Be decoction (BeD), effectively reduced neuropathic pain in diabetic animals, as shown by decreased latency to thermal stimulation and improved neurite outgrowth in nerve cells.

Both BGJTD and BeD treatments modulated key biochemical pathways, increasing phospho-Erk1/2 levels while decreasing TNF-α production, indicating their potential mechanisms of action in alleviating diabetic neuropathy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protective Effects of Bogijetong Decoction and Its Selected Formula on Neuropathic Insults in Streptozotocin-Induced Diabetic Animals. Kim, KJ., Namgung, U., Cho, CS.[2020]

DA 9801, a herbal medicine, shows potential in treating diabetic neuropathy by acting on mechanisms related to nerve growth factor (NGF), which is crucial for nerve regeneration.

Current treatments for diabetic neuropathy do not effectively address the underlying pathophysiological mechanisms, highlighting the need for innovative approaches like DA 9801 that target nerve regeneration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel botanical drug for the treatment of diabetic neuropathy. Choi, SZ., Son, MW.[2011]

NRD135S.E1 (NRD.E1) is a new oral medication developed for treating painful diabetic peripheral neuropathy, showing rapid absorption and good tolerability in three phase I studies involving healthy male and female subjects.

The studies demonstrated that NRD.E1's absorption is dose-dependent and increases when taken with food, with no significant accumulation in the body after daily doses, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First-in-Human Single-Ascending-Dose, Multiple-Dose, and Food Interaction Studies of NRD.E1, an Innovative Nonopioid Therapy for Painful Diabetic Peripheral Neuropathy. Tiecke, E., Rainisio, M., Guentert, T., et al.[2023]

Compound Qiying Granules (CQYG) significantly improved blood glucose levels and reduced nerve damage in diabetic peripheral neuropathy (DPN) models, indicating its potential as a therapeutic intervention.

CQYG demonstrated neuroprotective effects by inhibiting endoplasmic reticulum (ER) stress and apoptosis, as evidenced by changes in protein expression and improved nerve morphology in both rat and cell models of DPN.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Compound Qiying Granules alleviates diabetic peripheral neuropathy by inhibiting endoplasmic reticulum stress and apoptosis. Hu, Y., Chen, C., Liang, Z., et al.[2023]

J147, a curcumin derivative, shows promise in treating diabetic neuropathy in a mouse model, effectively improving nerve function and reducing pain associated with diabetes-induced nerve damage.

The drug works by decreasing neuroinflammation and may activate the AMP kinase pathway, suggesting it could be a single-agent alternative to the multiple medications typically needed to address the various causes of diabetic neuropathy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel curcumin derivative for the treatment of diabetic neuropathy. Daugherty, DJ., Marquez, A., Calcutt, NA., et al.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37252861/

First-in-human phase I studies of YJ001 spray applied to ... YJ001 appears to be well tolerated and potentially effective in the management of DNP and is a promising new remedy for DNP. Keywords: YJ001; diabetic ...

2. withpower.com withpower.com/trial/phase-1-diabetic-peripheral-neuropathic-pain-dpn-3-2024-a00bf

YJ001 Spray for Diabetic Neuropathy The meta-analysis of 8 studies involving 656 patients showed that Tongmai Jiangtang capsules (TJC) combined with conventional treatment significantly improved ...

3. semanticscholar.org semanticscholar.org/paper/42228551d9311433760970a0ff9ad2dd8d5c766d

First-in-human phase I studies of YJ001 spray applied to ... YJ001 appears to be well tolerated and potentially effective in the management of DNP and is a promising new remedy for DNP, which will reduce systemic ...

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06361108/mad-study-to-assess-the-safety-tolerability-pks-and-efficacy-of-yj001-for-spray-use-in-patients-with-dpnp

MAD Study to Assess the Safety, Tolerability, PKs and ... MAD Study to Assess the Safety, Tolerability, PKs and Efficacy of YJ001 for Spray Use in Patients With DPNP. Last updated: August 10, 2025.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06361108

NCT06361108 | MAD Study to Assess the Safety ... MAD Study to Assess the Safety, Tolerability, PKs and Efficacy of YJ001 for Spray Use in Patients With DPNP. ClinicalTrials.gov ID NCT06361108. Sponsor Zhejiang ...

6. app.trialscreen.org app.trialscreen.org/trials/phase-1-multiple-ascending-dose-to-assess-safety-tolerability-pharmacokinetics-trial-nct06361108

MAD Study to Assess the Safety, Tolerability, PKs and ... Back to study results. A Phase 1 study of YJ001 spray for diabetic neuropathic pain. A study to evaluate the safety, tolerability, and effectiveness of a ...

7. ctv.veeva.com ctv.veeva.com/study/the-effect-of-yj001-on-diabetic-peripheral-neuropathic-pain

The Effect of YJ001 on Diabetic Peripheral Neuropathic Pain. In this study, a randomized, double-blind, placebo parallel-controlled design was used to evaluate the effectiveness and safety of YJ001 spray ...