The purpose of this study is to assess the safety and tolerability of orally administered SK10 powders in healthy adult subjects at three dose levels, following single and multiple doses.
This is a first-in-human, Phase 1, randomized, double-blind, placebo-controlled, sequential SAD and MAD study to assess the safety and tolerability of orally administered SK10 powders in healthy adult subjects. This is a dose escalation study with three sequential cohorts planned testing at 3 dose levels. A total of 24 subjects are planned to be enrolled into 3 cohorts (Cohorts 1, 2 and 3). Within each cohort, eligible subjects will be randomized to receive SK10 or placebo in a 3:1 ratio. The treatment duration includes a single dose administration on Day 1 and 14-day repeat doses administration from Day 4 to Day 17. The study consists of: * Screening Period (28 days \[Day -28 to Day -1\]) * Treatment Period (Day -1 to Day 19) * Follow-up Visit (Day 24). The study duration will be approximately up to 52 days, conducted at a single center.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
24
Early Phase Clinical Unit (EPCU) - PAREXEL
Glendale, California, United States
Number of participants with Treatment-Emergent Adverse Events (TEAEs)
Number of participants with TEAEs to evaluate the safety and tolerability of SK10 in healthy adult subjects
Time frame: From screening (Day -28) up to follow-up [FU] (Days 24±2)
Number of participants with clinically relevant changes from baseline electrocardiogram (ECG) parameters
Number of participants with clinically relevant changes from baseline ECG parameters to evaluate the safety and tolerability of SK10 in healthy adult subjects
Time frame: From screening (Day -28), Days -1,1,3, 11,19 up to FU (Days 24±2)
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