Single-Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of YJ001 in Healthy Volunteers
Condition: Safety and Tolerability
Study type: Interventional
Phase: Phase 1

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.
    

Detailed 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.
    

Intervention name(s): YJ001 for Spray Use; Placebo of YJ001 for Spray Use
Intervention type(s): Drug; Drug
Intervention description(s): YJ001 (active ingredient); Hydroxypropyl Methylcellulose
Other intervention name(s): YJ001; Hydroxypropyl Methylcellulose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment