Actively Recruiting
MAD Study to Assess the Safety, Tolerability, PKs and Efficacy of YJ001 for Spray Use in Patients With DPNP
Led by Zhejiang Hanmai Pharmaceutical Technology Co., Ltd. · Updated on 2025-08-13
24
Participants Needed
1
Research Sites
110 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This Phase I, randomized, double-blind and placebo controlled study is to evaluate the safety, tolerability, and PK, and to preliminarily assess the efficacy of topically administered YJ001 in a multiple-ascending dose (MAD) fashion in the patients with DPNP. The study will be conducted at a single study center. In this study, 2 cohorts (N=24, 12 subjects for each cohort), each cohort will consist of 10 active and 2 placebo, with approximately equal numbers of male and female subjects. Each subject will be administered a single dose of YJ001 as multiple sprays topically on both feet and below the ankle in the morning on Day 1 and Day 2, and will be administered as twice daily doses once in the morning and the other in the evening (with an interval of 11 to 13 h) from Day 3 through Day 11.
CONDITIONS
Official Title
MAD Study to Assess the Safety, Tolerability, PKs and Efficacy of YJ001 for Spray Use in Patients With DPNP
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female, age 18 to 80 years inclusive at screening
- Voluntarily consented and able to understand informed consent in English or certified translation
- Body mass index (BMI) between 19 to 42 kg/m2
- Have two feet with five toes each and total surface area of at least 450 cm2 from below the ankle to toes
- Diagnosed with Type 1 or Type 2 diabetes and history of diabetic peripheral neuropathic pain for at least 3 months
- Optimized and stable glycemic control for at least 3 months prior to randomization using stable antidiabetic treatment
- Glycated hemoglobin (HbA1c) ≤ 10% at screening
- Weekly mean pain score of at least 4 on numeric rating scale from 7 days prior to drug administration
- Males agree not to donate sperm and use condoms during heterosexual activity for 90 days post last dose
- Females are postmenopausal, surgically sterile, or practicing effective contraception before and after study drug
- Able and willing to comply with all study requirements
You will not qualify if you...
- Participation in another investigational drug or device study or use of investigational drug within 30 days or 5 half-lives before dosing
- History of significant drug, food, or skin allergy related to similar drugs or hypersensitivity to YJ001 components
- History of asthma, except resolved childhood asthma
- Severe peripheral vascular disease or cardiovascular, cerebrovascular, gastrointestinal, or other serious diseases
- Chronic inflammatory demyelinating polyradiculoneuropathy or multifocal motor neuropathy
- History of moderate to severe depression or neurological/mental disorders affecting pain rating
- Severe hypoglycemia within 6 months prior to screening
- Pain scores less than 3 during one-week run-in period
- Unstable or poorly controlled blood pressure or lipid abnormalities
- Abnormal renal function (eGFR <60 mL/min/1.73 m2) or liver function (ALT/AST > 2 times upper limit)
- High alcohol consumption or history of drug/alcohol abuse within 6 months
- Smoking more than 5 cigarettes per day within 30 days before dosing or inability to stop tobacco/nicotine during trial
- Positive screening for alcohol/drugs of abuse or cotinine
- Positive SARS-CoV-2 test at screening or unwilling to comply with COVID-19 policies
- Pregnant or lactating females
- Significant acute illness or recent major illness/hospitalization
- Use of aspirin, salicylic acid products, sulfasalazine, blood thinners, or herbal supplements within specified timeframes
- Positive screening for Hepatitis B, Hepatitis C, or HIV
- History of blood donation over 500 mL in last 2 months
- Poor venous access or bleeding disorders
- Foot ulcers, pedal edema, or skin conditions interfering with study objectives
- Use of topical lotions, sunscreens, heating/cooling pads on feet within 24 hours before and until study end
- Employment or family relation to study center or sponsor
- Unwillingness to stay in clinic or consume provided meals as per protocol
- Scheduled surgery from screening through 7 days post dose
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Clinical Trials of Texas,LLC
Fredericksburg, Texas, United States, 78229
Actively Recruiting
Research Team
J
Jing Zhang
CONTACT
H
Hainan Yue
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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