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Tests treatment safety and results for Diabetic Peripheral Neuropathic Pain
Official title MAD Study to Assess the Safety, Tolerability, PKs and Efficacy of YJ001 for Spray Use in Patients With DPNP
ClinicalTrials.gov ID: NCT06361108
What this study is testing
What is YJ001 for Spray Use?
YJ001 for Spray Use is an investigational medicine, given as an once-daily treatment applied to the skin, being studied as a potential treatment for diabetic peripheral neuropathic pain.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Male or female, between the ages of 18 to 80 years at screening, both inclusive.
- people voluntarily consenting for participation in the study and having signed informed consent document. people are required to understand verbal...
- Body mass index (BMI) between 19 to 42 kg/m2 (both inclusive) at screening, calculated as weight (kg)/height2 (m2). people must have two feet. Each...
- The subject is diagnosed with Type 1 or Type 2 diabetes, and has a history of DPNP for at least 3 months based on participant report or medical...
- The subject should have a glycemic control that has been optimized and has been stable for at least 3 months prior to randomization. The subject has...
You likely can't join if
- Current participation in another investigational drug or device study or treated with an investigational drug within 30 days or 5 half-lives...
- History of clinically significant drug, food allergy, skin allergy, or sensitivity to drugs of the same class (e.g., 5-aminosalicylic acid...
- History of asthma. Adults with history of benign (resolved) childhood asthma may be included.
- Any subject who suffers severe peripheral vascular disease (e.g., intermittent claudication) at screening, and is not suitable to be involved in the...
- Any subject who suffers severe cardiovascular and cerebrovascular disease (e.g., severe arrhythmia, heart failure, myocardial infarction, unstable...
- Any subject who suffers chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) or multifocal motor neuropathy (MMN).
See the full eligibility criteria
Who can join
- Male or female, between the ages of 18 to 80 years at screening, both inclusive.
- people voluntarily consenting for participation in the study and having signed informed consent document. people are required to understand verbal and/or written English or any other language in which a certified...
- Body mass index (BMI) between 19 to 42 kg/m2 (both inclusive) at screening, calculated as weight (kg)/height2 (m2). people must have two feet. Each foot must have five digits. Each foot must have at least total surface...
- The subject is diagnosed with Type 1 or Type 2 diabetes, and has a history of DPNP for at least 3 months based on participant report or medical history.
- The subject should have a glycemic control that has been optimized and has been stable for at least 3 months prior to randomization. The subject has used a stable regimen of antidiabetic agents (oral) and/or insulin for...
- Glycated hemoglobin (HbA1c) ≤ 10% at screening.
- Participants who have a weekly mean score of at least 4 based upon the daily mean scores using 11-point Numeric Rating Scale (NRS) in the daily diary (rated twice daily, once in the morning and the other in the evening)...
- Males must not donate sperm until 90 days after last dose of study drug and must be willing to use a condom during heterosexual activity for up to 90 days after the application of the study drug.
- Females must be either postmenopausal for at least 1 year, surgically sterile (bilateral tubal ligation [including clip, cauterization methods and coil], bilateral oophorectomy or hysterectomy, and needs to be confirmed...
- Intrauterine device (IUD) or IUD hormone-releasing system.
- Combined estrogen and progestogen containing hormonal contraception (oral, intravaginal, or transdermal) associated with inhibition of ovulation.
- Progesterone-only hormonal contraception (oral, injectable, implantable) associated with inhibition of ovulation.
- Intrauterine hormone-releasing system.
- Double-barrier method (condoms, contraceptive sponge, diaphragm, or vaginal ring with spermicide).
- Able and willing to comply with all study requirements.
What rules you out
- Current participation in another investigational drug or device study or treated with an investigational drug within 30 days or 5 half-lives, whichever is longer, before dosing.
- History of clinically significant drug, food allergy, skin allergy, or sensitivity to drugs of the same class (e.g., 5-aminosalicylic acid, sulfasalazine, and salicylates) or known hypersensitivity to YJ001 or any of...
- History of asthma. Adults with history of benign (resolved) childhood asthma may be included.
- Any subject who suffers severe peripheral vascular disease (e.g., intermittent claudication) at screening, and is not suitable to be involved in the study as per investigator evaluation.
- Any subject who suffers severe cardiovascular and cerebrovascular disease (e.g., severe arrhythmia, heart failure, myocardial infarction, unstable angina pectoris, atherosclerosis, stroke, sequela of stroke, etc.)...
- Any subject who suffers chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) or multifocal motor neuropathy (MMN).
- Any subject who has a history of moderate to severe depression, obvious neurological or mental disorder not related to neuropathic pain but may interfere with rating of pain, as well as poly neuropathy, numbness...
- Any other medical, psychological, or social condition which, in the opinion of the Investigator, would prevent the subject from fully participating in the study, would represent a concern for study compliance, or would...
- Any subject who has suffered one or more severe hypoglycemia event (defined as neurofunctional hypoglycemia that needs third-party assistance) within 6 months prior to screening.
- Pain scores \< 3 on the NRS over twice during the one-week run-in period.
- Any subject with unstable or poorly controlled abnormality in blood pressure or lipid (blood pressure ≥ 160 mmHg/95 mmHg, total cholesterol ≥ 6.2 mmol/L, and/or triglyceride ≥ 6.3 mmol/L) at screening.
- Any subject with abnormal renal function, estimated glomerular filtration rate (eGFR)\<60 mL/min/1.73 m2. eGFR=186×Scr\^-1.154×Age\^-0.203×(0.742 for Female)
- Any subject with abnormal liver function, liver enzymes (alanine aminotransferase [ALT] and aspartate aminotransferase [AST]) greater than 2 times upper limit of normal.
- Consumed 8 units or more of alcoholic beverages per week for women or 15 units or more of alcoholic beverages per week for men at any time in the 6 months before dosing (1 unit of ethanol is equivalent to 12 ounces of...
- Any subject who consumes more than 5 cigarettes per day within 30 days before study drug dosing or who cannot stop using any tobacco- or nicotine-containing product during the duration of the trial.
- Positive screening or check-in alcohol/drugs of abuse/cotinine screen.
- Positive test results for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at Screening. SARS-CoV-2 testing will be either antigen, nasopharyngeal (NP) or nasal swab polymerase chain reaction (PCR) performed...
- Female volunteers who are pregnant or lactating.
- Have a significant acute illness within 7 days prior to study drug administration or have had a major illness or hospitalization within 1 month prior to study drug administration.
- Systemic or topical use of aspirin or salicylic acid containing products or sulfasalazine/salicylic acid derivatives within 14 days of study drug dosing.
- Use of other prescription and non-prescription medications (with the exception of permitted concomitant medications, oral contraceptives, combined estrogen and progestogen containing hormonal contraception and...
- Positive screen on Hepatitis B, Hepatitis C, or Human immunodeficiency virus (HIV) at the time of screening evaluations.
- History of blood donation of more than 500 mL in the last 2 months prior to screening.
- History or evidence of poor venous access.
- History of bleeding disorders.
- Any subject with foot ulcers and/or pedal oedema. Presence of skin disorders, tattoos, skin breakdown, or other skin conditions on either foot that may interfere with the objectives of the study (as per investigator...
- Use of any kind of topical lotions, sunscreen, heating pads/cooling pads on feet for at least 24 hours before study drug is administered and until End-of-Study.
- An employee of the study center or Sponsor or family member of a study center employee
- Unwilling to stay in the clinical unit for the required duration as per the protocol or consume the standard meal to be provided as per the protocol.
- Any subject considering or scheduled to undergo any surgical procedure from screening to at least 7 days post dose.
The study team makes the final eligibility decision.
Where it's taking place
- Fredericksburg, Texas, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fredericksburg, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.