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
Zhejiang Hanmai Pharmaceutical Technology Co., Ltd.
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.
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. Th…
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Male or female, between the ages of 18 to 80 years at screening, both inclusive. * Subjects voluntarily consenting for participation in the study and having signed informed consent document. Subjects are required to understand verbal and/or written English or any other language in which a certified translation of the informed consent is available. * Body mass index (BMI) between 19 to 42 kg/m2 (both inclusive) at screening, calculated as weight (kg)/height2 (m2). Subjects must have two feet. Each foot must have five digits. Each foot must have at least total surface area…
Interventions
- DrugYJ001 for Spray Use
Granules for spray use; Preparation of Dosing Solution: Reconstitute with sterile water (50ml)
- DrugPlacebo of YJ001 for Spray Use
Inactive Ingredient: Sterile water; Preparation of Dosing Solution: 50ml Sterile water
Location
- Clinical Trials of Texas,LLCFredericksburg, Texas