NCT06361108

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

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 DPNP

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Zhejiang Hanmai Pharmaceutical Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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 between ages of 18 to 80 years. The study will be conducted at a single study center. In this study, 2 cohorts (N=24, 12 subjects for each cohort), the doses of which are 296 mg/administration (Cohort M1) and 414 mg/administration (Cohort M2), are planned. Each cohort will enroll approximately equal numbers of male and female subjects. The administration area is set as 450 cm2 (both feet). Each subject will be administered a single dose of YJ001 as multiple sprays (16 sprays/foot for Cohort M1, and 12 sprays/foot for Cohort M2) 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. Each cohort will consist of 12 subjects (10 active; 2 placebo), with approximately equal numbers of male and female subjects. Each cohort will be evaluated separately for safety and PK to allow for dose escalation based on stopping criteria per protocol. 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 decision whether to escalate the dose will be made for a completed cohort based on available safety data through Day 17 (5 days post the last dose), and blinded PK data \[maximum observed plasma concentration (Cmax,ss) and area under the concentration-time curve through the first 48 hours post the last dose (AUC0-48h,ss)\]. 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. Subjects will be screened between Day -28 through Day -7, rate the scores on Numeric Rating Scale (NRS) twice daily (once in the morning and the other in the evening) from Day -7 to Day -1, and will be admitted to the clinic on Day-1. Subjects will be housed within the clinic from Day -1 through Day 17 and will be discharged on Day 17 after all scheduled study procedures have been completed. If necessary, subjects will receive a telephone follow-up 2 days post discharge for documentation of any adverse event or concomitant medication. Safety,Pharmacokinetics and Efficacy will be evaluated.

Conditions

• Diabetic Peripheral Neuropathic Pain

Interventions

Type	Name	Description
DRUG	YJ001 for Spray Use	Granules for spray use; Preparation of Dosing Solution: Reconstitute with sterile water (50ml)
DRUG	Placebo of YJ001 for Spray Use	Inactive Ingredient: Sterile water; Preparation of Dosing Solution: 50ml Sterile water

Timeline

• Start date: 2024-05-16
• Primary completion: 2025-12-20
• Completion: 2026-06-30
• First posted: 2024-04-11
• Last updated: 2025-08-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study