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

Part of paid clinical trials in Fredericksburg, Texas.

Sponsor
Zhejiang Hanmai Pharmaceutical Technology Co., Ltd.
Study ID
NCT06361108
Phase
PHASE1
Status
Recruiting
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Conditions

  • Diabetic Peripheral Neuropathic Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
May 16, 2024
Status verified
Aug 2025
Primary completion
Dec 20, 2025
Completion
Jun 30, 2026

Study Design

Enrollment
24 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort M1 (10active, 2 placebo)
    296 mg/administration
  • Experimental: Cohort M2 (10 active, 2 placebo)
    414 mg/administration

Primary Outcome Measure

Safety Assessments - AEs [ Time Frame: through study completion, an average of 1year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Clinical Trials of Texas,LLCFredericksburgTexas78229
Douglas Scott Denham
210-949-0122

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By research site
Clinical Trials of Texas,LLC· Fredericksburg, TX

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