This clinical trial is the first-in-human study of Kylo-0603. The purpose of this randomized, double-blind, placebo-controlled phase 1 study is to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and effect of food of Kylo-0603 in healthy Chinese adult subjects.
The study consists of three parts: single ascending doses (Part 1), food effect (Part 2) and multiple ascending doses (Part 3).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
132
Administrated orally.
Administrated orally.
The first affiliated hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
incidence of adverse events
Time frame: up to 3 weeks
Pharmacokinetics (PK) parameter of maximum observed concentration (Cmax)
Time frame: up to 3 weeks
PK parameter of time of maximum observed concentration (Tmax)
Time frame: up to 3 weeks
PK parameter of area under the concentration time curve (AUC)
Time frame: up to 3 weeks
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