Actively Recruiting
A Phase I, Randomized, Double-Blind, Placebo Controlled MAD Study to Assess the Safety, Tolerability, PKs and Efficacy of Topical Application of YJ001 for Spray Use in Patients With Diabetic Peripheral Neuropathic Pain
Led by Zhejiang Hanmai Pharmaceutical Technology Co., Ltd. · Updated on 2025-08-13
24
Participants Needed
1
Research Sites
27 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of a topical spray called YJ001 for patients with diabetic peripheral neuropathic pain (DPNP). This Phase I, randomized, double-blind, placebo-controlled study includes adults aged 18 to 80 years and is conducted at a single study center. The study involves two dose levels and aims to assess multiple ascending doses applied topically to both feet and below the ankles. Participants are assigned to one of two cohorts receiving either 296 mg or 414 mg doses of YJ001, each cohort including 12 subjects with 10 receiving the active spray and 2 receiving placebo. The treatment is administered as multiple sprays on both feet once in the morning on Days 1 and 2, then twice daily (morning and evening) from Days 3 to 11. The Safety Review Committee evaluates safety and pharmacokinetics data after each cohort to decide on dose escalation or other study actions. Before starting treatment, subjects undergo screening and a baseline pain rating period from Day -7 to Day -1. They stay in the clinic from Day -1 through Day 17 for treatment and observation, with follow-up by phone 2 days after discharge. Researchers monitor safety through adverse events, laboratory tests, and skin reactions for about one year. Pharmacokinetics and efficacy are assessed through various measurements during and after dosing, ensuring detailed evaluation of the treatment's effects and tolerability.
CONDITIONS
Brief 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, between the ages of 18 to 80 years at screening
- Voluntarily consent to participate and able to understand informed consent in English or a certified translated language
- Body mass index (BMI) between 19 to 42 kg/m2
- Have two feet, each with five digits and at least 450 cm2 surface area 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
- Stable and optimized glycemic control for at least 3 months prior to randomization
- Glycated hemoglobin (HbA1c) ≤ 10% at screening
- Weekly mean pain score of at least 4 on the 11-point Numeric Rating Scale recorded twice daily during the 7 days before treatment
- Males must agree to use condoms during heterosexual activity for 90 days after dosing and not donate sperm during this time
- Females must be postmenopausal, surgically sterile, or practicing effective contraception as specified
- Able and willing to comply with all study requirements
You will not qualify if you...
- Currently participating in another investigational drug or device study or treated with an investigational drug within 30 days or 5 half-lives before dosing
- History of significant drug, food, or skin allergy or hypersensitivity to YJ001 or related drugs
- History of asthma (except resolved childhood asthma)
- Severe peripheral vascular disease or severe cardiovascular, cerebrovascular, gastrointestinal, or other serious diseases that prevent full participation
- Chronic inflammatory demyelinating polyradiculoneuropathy or multifocal motor neuropathy
- History of moderate to severe depression or neurological/mental disorders affecting pain rating
- Severe hypoglycemia requiring assistance within 6 months prior to screening
- Pain scores less than 3 on Numeric Rating Scale during the one-week run-in period
- Unstable or uncontrolled blood pressure or lipid abnormalities at screening
- Abnormal renal function with eGFR < 60 mL/min/1.73 m2
- Abnormal liver function with elevated liver enzymes greater than twice the normal limit
- Excessive alcohol consumption or history of drug or alcohol abuse within 6 months prior to dosing
- Smoking more than 5 cigarettes per day within 30 days before dosing or inability to stop tobacco use during the trial
- Positive screening for alcohol, drugs of abuse, or cotinine
- Positive test for SARS-CoV-2 at screening
- Pregnant or lactating females
- Significant acute illness within 7 days or major illness/hospitalization within 1 month prior to dosing
- Use of certain medications including aspirin, salicylic acid derivatives, blood thinners, herbal products, or supplements within specified timeframes before dosing
- Positive screening for Hepatitis B, Hepatitis C, or HIV
- History of donating more than 500 mL blood in last 2 months
- History of poor venous access or bleeding disorders
- Presence of foot ulcers, pedal edema, or skin conditions interfering with study objectives
- Use of topical lotions, sunscreen, heating or cooling pads on feet within 24 hours before dosing
- Employment or family relation to study center or sponsor staff
- Unwillingness to stay in clinic or consume provided meals during study
- Scheduled surgical procedures from screening to 7 days post dose
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for screening assessments
Duration - 7 days
Participants rate their pain scores twice daily to establish baseline measurements before treatment.
Daily self-assessments twice daily from Day -7 to Day -1
Duration - 11 days
Participants receive topical doses of YJ001 or placebo applied twice daily to both feet for up to 11 days while staying in the clinic.
In-clinic dosing with twice daily administration from Day 1 through Day 11
Duration - 6 days
Participants remain in the clinic for safety monitoring and pharmacokinetic assessments after treatment ends, followed by a telephone follow-up if needed.
Continuous in-clinic monitoring until Day 17, plus 1 telephone follow-up 2 days after discharge
Trial Site Locations
Total: 1 location
1
Clinical Trials of Texas,LLC
Fredericksburg, Texas, United States, 78229
Actively Recruiting
Research Team
J
Jing Zhang
H
Hainan Yue
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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