The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending doses of ABP-671 administered orally in healthy volunteers.
Primary Objectives: • To assess the safety and tolerability of single ascending oral doses of ABP-671 in Healthy Volunteers (HVs). Secondary Objectives: • To characterize the pharmacokinetics (PK) and pharmacodynamics (PD) profiles of single ascending oral doses of ABP-671 in HVs.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
32
Celerion
Tempe, Arizona, United States
Incidence of adverse events
Incidence of adverse events
Time frame: baseline to 7 days
Maximum tolerable dose
Maximum tolerable dose
Time frame: baseline to 7 days
Peak plasma concentration
Peak plasma concentration
Time frame: baseline to 72 hours
half-life
half-life
Time frame: baseline to 72 hours
area under the curve
area under the curve
Time frame: baseline to 72 hours
volume of distribution
volume of distribution
Time frame: baseline to 72 hours
level of serum and urine uric acid
level of serum and urine uric acid
Time frame: baseline to 72 hours
level of serum and urine creatinine
level of serum and urine creatinine
Time frame: baseline to 72 hours
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