Single-Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of YJ001 in Healthy Volunteers

Safety and Tolerability Clinical Trial

Official title: A Phase I, Randomized, Double-Blind, Placebo Controlled Single-Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of Topical Application of YJ001 in Healthy Volunteers

Status Completed

Clinical Trial Summary

This phase I, randomized, double-blind, placebo controlled study is to investigate the safety, tolerability and pharmacokinetics (PK) of topically administered YJ001 in a single-ascending dose (SAD) fashion in healthy volunteers between 18 to 55 years of age, to establish the dosage range for spray use, and to provide a dosage regimen for Phase I multiple-ascending dose (MAD) study in healthy subjects. The study is to enroll 4 cohorts, the doses of which are 148, 296, 552 and 828 mg, with the option to enroll 2 additional cohorts (8 subjects for each cohort) without requiring a protocol amendment. Subjects will be screened between Day -28 and Day -2 and will be admitted to the clinic on Day -1. Subjects will be housed within the clinic from Day -1 through Day 8 and will be discharged on Day 8 after all scheduled study procedures have been completed.

Clinical Trial Description

This phase I, randomized, double-blind, placebo controlled study is to investigate the safety, tolerability and pharmacokinetics (PK) of topically administered YJ001 in a single-ascending dose (SAD) fashion in healthy volunteers between 18 to 55 years of age, to establish the dosage range for spray use, and to provide a dosage regimen for Phase I multiple-ascending dose (MAD) study in healthy subjects. The study is to enroll 4 cohorts, the doses of which are 148, 296, 552 and 828 mg, with the option to enroll 2 additional cohorts (8 subjects for each cohort) without requiring a protocol amendment. Each cohort will consist of 8 subjects (6 active; 2 placebo). Each subject will be administered a single dose of YJ001 as multiple sprays (8 sprays/foot for Cohort 1, 16 sprays/foot for Cohort 2, 16 sprays/foot for Cohort 3, and 24 sprays/foot for Cohort 4) topically on both feet; and below the ankle, with the administration area set as 450 cm2 (both feet).

Safety will be evaluated by assessing incidence and severity of adverse events (AEs) and serious adverse events (SAEs); observed values and changes in baseline of clinical safety laboratory test results, 12-lead electrocardiogram (ECG), vital signs; and physical examination inclusive of skin reaction findings at the Investigational Product (IP) administration sites.

For pharmacokinetics evaluation, serial blood samples will be collected in the subjects of Cohorts 2 to 4 for up to 7 days following a single dose to assess the PK of YJ001 and metabolites in plasma. Pooled urine samples will be collected in the subjects of Cohorts 2 to 4 to evaluate renal excretion of YJ001 and metabolites.

Subjects will be screened between Day -28 and Day -2 and will be admitted to the clinic on Day -1. Subjects will be housed within the clinic from Day -1 through Day 8 and will be discharged on Day 8 after all scheduled study procedures have been completed. ;

Related Conditions & MeSH terms

• Safety and Tolerability

• NCT number: NCT05451667
• Study type: Interventional
• Source: Zhejiang Yuejia Pharmaceuticals Co., Ltd.
• Status: Completed
• Phase: Phase 1
• Start date: August 15, 2022
• Completion date: December 20, 2022