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

NCT06361108 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-08-13

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Zhejiang Hanmai Pharmaceutical Technology Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Douglas Scott Denham · 5430 Fredericksburg Rd, Suite 200, San Antonio Texas 78229

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-16
Primary Completion
2025-12-20
Completion
2026-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06361108 on ClinicalTrials.gov