This study will assess the safety, tolerability, pharmacokinetics (PK) and anti-viral effect of single dose of AK0529 in infants hospitalized with respiratory syncytial virus (RSV).
This is a open-label Phase 1b study to evaluate the safety, tolerability, pharmacodynamics and Pharmacokinetics of AK0529 in hospitalized RSV infected infants age from 1 to 24 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1
AK0529 pellets for oral administration
Women's & Children's Hospital
Adelaide, South Australia, Australia
Number of Adverse Events
Time frame: Baseline through 7 days post administration
Pharmacokinetics parameters, including maximum and minimum of drug concentration
Time frame: Baseline through 3 days post administration
Pharmacokinetics parameters, including time to maximum concentration and half-time
Time frame: Baseline through 3 days post administration
Pharmacokinetics parameters, including area under concentration-time curves (AUC)
Time frame: Baseline through 3 days post administration
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