MAD Study to Assess the Safety, Tolerability, PKs and Efficacy of YJ001 for Spray Use in Patients With DPNP

NCT06361108 | Recruiting Phase 1 FDA Drug

• 1 other identifier: YJ001-103
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Diabetic Peripheral Neuropathic Pain

Keywords

Diabetes; Diabetic Peripheral Neuropathic(DPN); Diabetic Peripheral Neuropathic Pain(DPNP)

Outcome Measures

Primary Outcomes (3)

• Safety Assessments - AEs

  Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)

  through study completion, an average of 1year

• Safety Assessments -Number of Participants With Abnormal Laboratory Values

  Observed values and changes in baseline of clinical safety laboratory parameters

  through study completion, an average of 1year

• Safety Assessments - Skin Reaction

  Administration site assessment

  through study completion, an average of 1year

Secondary Outcomes (10)

• Pharmacokinetics-AUC

  Day 1-Day 28

• Pharmacokinetics- Cmax

  Day 1-Day 28

• Pharmacokinetics - tmax

  Day 1-Day 28

• Pharmacokinetics - tlag

  Day 1

• Pharmacokinetics - t1/2

  Day 1-Day 28

Study Arms (2)

Cohort M1 (10active, 2 placebo)

EXPERIMENTAL

296 mg/administration

Drug: YJ001 for Spray Use; Drug: Placebo of YJ001 for Spray Use

Cohort M2 (10 active, 2 placebo)

EXPERIMENTAL

414 mg/administration

Drug: YJ001 for Spray Use; Drug: Placebo of YJ001 for Spray Use

Interventions

YJ001 for Spray Use DRUG

Granules for spray use; Preparation of Dosing Solution: Reconstitute with sterile water (50ml)

Cohort M1 (10active, 2 placebo); Cohort M2 (10 active, 2 placebo)

Placebo of YJ001 for Spray Use DRUG

Inactive Ingredient: Sterile water; Preparation of Dosing Solution: 50ml Sterile water

Cohort M1 (10active, 2 placebo); Cohort M2 (10 active, 2 placebo)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, between the ages of 18 to 80 years at screening, both inclusive.
• Subjects voluntarily consenting for participation in the study and having signed informed consent document. Subjects are required to understand verbal and/or written English or any other language in which a certified translation of the informed consent is available.
• Body mass index (BMI) between 19 to 42 kg/m2 (both inclusive) at screening, calculated as weight (kg)/height2 (m2). Subjects must have two feet. Each foot must have five digits. Each foot must have at least total surface area of 450 cm2 measured from below the ankle to the toes including both dorsum and plantar areas.
• 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 at least 3 months before screening.
• 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) from Day -7 through Day 1 (should be calculated from records 7 days immediately prior to study drug administration).
• 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 follicle-stimulating hormone \[FSH\] level \>40 IU/L), or of childbearing potential either practicing true abstinence or practicing 2 effective means of contraception for at least 4 weeks prior to randomization, and until 28 days after study drug administration:
• 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.

You may not qualify if:

• 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 its components.
• 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.), severe gastrointestinal tract disease or other serious disease (e.g., cancer) which, in the opinion of the Investigator, would prevent the subject from fully participating in the study.
• 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, feeling of pins and needles and weakness in extremities, other serious pain cannot be clearly differentiated from or conditions that may interfere with rating of neuropathic pain. Subjects with weakness but w/o sensory complaints may be included.
• 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 constitute a safety concern to the subject.
• 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 beer, 5 ounces of wine, or 1.5 ounces of spirits) or history of drug or alcohol abuse within the 6 months before dosing or evidence of such abuse as indicated by inquiry, medical history or the laboratory assays conducted during screening. Any subject who has past history of heavy drinking or alcoholism.

Sponsors & Collaborators

• Zhejiang Hanmai Pharmaceutical Technology Co., Ltd.: lead

Study Sites (1)

Clinical Trials of Texas,LLC

Fredericksburg, Texas, 78229, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Douglas Scott Denham

  5430 Fredericksburg Rd, Suite 200, San Antonio Texas 78229

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jing Zhang

CONTACT

86+18602195085; zhangjing@zjhanmai.com

Hainan Yue

CONTACT

86+13166206612; yuehainan@yuejiabiotech.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blinded with regard to the study treatment that subjects receive,without the investigator, the sponsor, or the subjects being aware of wether YJ001 or the placebo is administered. All decisions concerning dose escalation will be made in a blinded manner by the safety review committee. The Safety Review Committee (SRC), comprised of the Principal Investigator, Medical Monitor, and Sponsor's qualified designee, will convene after completion of each cohort to evaluate available safety, PK, and other relevant data. The SRC will determine whether to proceed to the next planned dose level, continue with the study and add additional safety evaluations, expand the number of subjects at the current level, reduce the dose, or stop the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2024
• First Posted: April 11, 2024
• Study Start: May 16, 2024
• Primary Completion: December 20, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: August 13, 2025

Record last verified: 2025-08

Locations

US (1)