Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT06361108
PHASE1

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

Sponsor: Zhejiang Hanmai Pharmaceutical Technology Co., Ltd.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

24

Start Date

2024-05-16

Completion Date

2026-06-30

Last Updated

2025-08-13

Healthy Volunteers

No

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

Locations (1)

Clinical Trials of Texas,LLC

Fredericksburg, Texas, United States