First in human study
Study to evaluate the safety and tolerability, pharmacokinetics/pharmacodynamics (PK/PD) parameters of an escalating, single dose/repeat doses of YH4808 in healthy subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
134
YH4808 30mg (single dose)
YH4808 50mg (single dose)
YH4808 100mg (single dose)
Clinical trials center, Seoul national university hospital
Seoul, South Korea
To evaluate the PKs, PDs, safety and tolerability of escalating, single/multiple oral doses of YH4808
Time frame: Throughout the study
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YH4808 200mg (single dose)
YH4808 400mg (single dose)
YH4808 100mg (repeat dose)
YH4808 200mg (repeat dose)
YH4808 600mg
YH4808 800mg (single dose)
YH4808 400 mg (repeat doses)
10 volunteers will be administered matched placebo.
24 volunteers will be administered Esomeprazole 40mg