This is a first-in-human, randomized, double-blind, placebo-controlled, single ascending dose study in healthy volunteers. Kylo-12 will be evaluated in approximately 50 subjects to assess safety, tolerability, pharmacokinetics and pharmacodynamic effects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
50
Chengdu Xinhua Hospital
Chengdu, Sichuan, China
Incidence of adverse events
Time frame: up to Week 24
Incidence of adverse events
Time frame: up to week 48
Pharmacokinetics (PK) parameter of maximum observed concentration (Cmax)
Time frame: up to Week 48
PK parameter of time of maximum observed concentration (Tmax)
Time frame: up to Week 48
PK parameter of area under the concentration time curve (AUC)
Time frame: up to Week 48
Change in serum ApoC3 and TG over time
Time frame: up to Week 48
Percent change in serum ApoC3 and TG over time
Time frame: up to Week 48
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