MAD Study to Assess the Safety, Tolerability, PKs and Efficacy of YJ001 for Spray Use in Patients With DPNP
NCT06361108
This study is recruiting at 1 US site in 1 state, according to its ClinicalTrials.gov record last updated .
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.
Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov
Conditions studied
- Diabetic Peripheral Neuropathic Pain
Eligibility basics and study details
- Study type
- Interventional
- Phase
- Phase 1
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Sponsor
- Zhejiang Hanmai Pharmaceutical Technology Co., Ltd.
- Last updated on ClinicalTrials.gov
- August 13, 2025
These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.
US recruiting sites
Texas · 1
- Clinical Trials of Texas,LLC · Fredericksburg, TX
Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.