The purpose of this study is to evaluate the safety, activity and pharmacokinetics of a new investigational drug (HQK-1001) in healthy human volunteers. This study will also evaluate if there are differences in these parameters when HQK-1001 is administered in a fed versus a fasted state.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
41
Charles River Clinical Services Northwest
Tacoma, Washington, United States
Safety as assessed by (1) adverse events, (2) laboratory values (3) vital signs (4) physical exam
Time frame: 41 days
Pharmacokinetics assessed by plasma drug concentration levels
Time frame: 15 days
Pharmacodynamics assessed by red blood cell production and induction of fetal hemoglobin
Time frame: 41 days
Comparison of safety, PK and PD under fed versus fasting conditions
Time frame: 41 days
Comparison of safety and PK when oral iron is administered with HQK-1001.
Time frame: 41 days
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