The objective of this study is to assess the safety and tolerability of ASP5354 administered intravenously as a single dose to healthy subjects. This study will also assess the single dose pharmacokinetics of ASP5354 in plasma and urine.
This is a study comprising of 5 cohorts (cohorts 1 to 5) of 6 healthy subjects in each cohort (4 in each ASP5354 cohort and 2 in each placebo cohort). If the data from cohorts 1 to 3 are sufficient to characterize safety, tolerability and pharmacokinetics and the assessed doses reach the expected urine ASP5354 concentration, the study may be ended without running the fourth or fifth cohorts.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
30
Covance CRU, Daytona Beach
Daytona Beach, Florida, United States
Safety and tolerability assessed by nature, frequency, and severity of Adverse Events (AEs)
An AE is any untoward medical occurrence in a participants administered ASP5354, and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of a medicinal product whether or not considered related to the medicinal product. AEs will be coded using MedDRA.
Time frame: Up to Day 14
Number of participants with laboratory value abnormalities and/or AEs
Number of participants with potentially clinically significant laboratory values.
Time frame: Up to Day 7
Number of participants with vital sign abnormalities and /or AEs
Number of participants with potentially clinically significant vital sign values.
Time frame: Up to Day 7
Safety and tolerability assessed by 12-lead electrocardiogram (ECG)
12-lead ECGs will be taken after the subject has been resting in the supine position for at least 5 minutes. 12 lead ECGs will be taken in triplicate.
Time frame: Up to Day 7
Number of participants with physical exam abnormalities and/or adverse events (AEs)
Number of participants with potentially clinically significant physical exam values.
Time frame: Up to Day 7
Pharmacokinetics (PK) of ASP5354 in plasma: plasma concentration at time 0 (C0)
C0 will be derived from the PK samples collected.
Time frame: Before dosing on Day 1
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
PK of ASP5354 in plasma: area under the concentration-time curve from time zero to 24 hours postdose (AUC0-24)
AUC0-24 will be derived from the PK samples collected.
Time frame: Up to 24 hr after dosing
PK of ASP5354 in plasma: AUC extrapolated from time to infinity as a percentage of total area under the concentration-time curve (AUCinf)
AUCinf will be derived from the PK samples collected.
Time frame: Up to 24 hr after dosing
PK of ASP5354 in plasma: AUC from time zero to the time of the last quantifiable concentration (AUClast)
AUClast will be derived from the PK samples collected.
Time frame: Up to 24 hr after dosing
PK of ASP5354 in plasma: AUC extrapolated from time to infinity as a percentage of total area under the concentration-time curve (AUCinf(%extrap))
AUCinf (%extrap) will be derived from the PK samples collected.
Time frame: Up to 24 hr after dosing
PK of ASP5354 in plasma: maximum concentration (Cmax)
Cmax will be derived from the PK samples collected.
Time frame: Up to 24 hr after dosing
PK of ASP5354 in plasma: total body clearance of drug from plasma (CL)
CL will be derived from the PK samples collected.
Time frame: Up to 24 hr after dosing
PK of ASP5354 in plasma: time of maximum concentration (tmax)
tmax will be derived from the PK samples collected.
Time frame: Up to 24 hr after dosing
PK of ASP5354 in plasma: apparent terminal elimination half-life (t1/2)
t1/2 will be derived from the PK samples collected.
Time frame: Up to 24 hr after dosing
PK of ASP5354 in plasma: volume of distribution during terminal phase (Vz)
Vz will be derived from the PK samples collected.
Time frame: Up to 24 hr after dosing
PK of ASP5354 in urine: amount of unchanged drug excreted into the urine (Ae)
Ae will be derived from the PK samples collected.
Time frame: Up to 24 hr after dosing
PK of ASP5354 in urine: percentage of dose excreted in the urine (Ae%)
Ae% will be derived from the PK samples collected.
Time frame: Up to 24 hr after dosing
PK of ASP5354 in urine: cumulative amount of unchanged drug excreted into the urine (CumAe)
CumAe will be derived from the PK samples collected.
Time frame: Up to 24 hr after dosing
PK of ASP5354 in urine: cumulative percentage of dose excreted in the urine (CumAe%)
CumAe% will be derived from the PK samples collected.
Time frame: Up to 24 hr after dosing
PK of ASP5354 in urine: amount of unchanged drug excreted into the urine from time zero to the time of the last quantifiable concentration (Aelast)
Aelast will be derived from the PK samples collected.
Time frame: Up to 24 hr after dosing
PK of ASP5354 in urine: percent of unchanged drug excreted into the urine from time zero to the time of the last quantifiable concentration (Aelast%)
Aelast% will be derived from the PK samples collected.
Time frame: Up to 24 hr after dosing
PK of ASP5354 in urine: renal clearance (CLR)
CLR will be derived from the PK samples collected.
Time frame: Up to 24 hr after dosing
PK of ASP5354 in urine: mean ASP5354 urine concentrations at each time point
Mean ASP5354 urine concentrations will be derived from the PK samples collected.
Time frame: Up to 24 hr after dosing