Respiratory Syncytial Virus Infections
Conditions
Brief summary
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).
Detailed description
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.
Interventions
DRUGAK0529
AK0529 pellets for oral administration
Sponsors
Shanghai Ark Biopharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Months to 24 Months
Healthy volunteers
No
Inclusion criteria
* Male or female subjects of any race or ethnicity with an age adjusted for any prematurity of ≥1 month and ≤24 months. * Diagnosis of RSV infection by virological. * Subject must weigh \>3 kg at screening. * Must have provided written informed consent for the subject to participate. * For patients aged \<12 months, and occipitofrontal head circumference (OFHC) within the normal range for age and gender.
Exclusion criteria
* The subject has taken, is currently taking or requires any restricted medications. * Subject is known to be HIV-positive (or the mother, if the potential subject is a child aged \<6 months). * Participation in an investigational drug or device study within 30 days prior to the date of screening. * Requires vasopressors or inotropic support at the time of enrollment. * Concurrent gastrointestinal conditions that could, in the opinion of the investigator, prejudice absorption of the Investigational Medicinal Product (e.g. protracted vomiting, malabsorption syndrome, a history of necrotising enterocolitis with consequent short gut syndrome). * Bronchopulmonary dysplasia or chronic lung disease requiring assisted ventilation at the time of enrollment. * Diminished ventilatory reserve at risk for hypercapnia (e.g. pulmonary hypoplasia, sequestration syndromes, cystadenomatoid malformation, a history of surgery for diaphragmatic hernia). * Left to right shunt meriting corrective therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Adverse Events | Baseline through 7 days post administration |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics parameters, including maximum and minimum of drug concentration | Baseline through 3 days post administration |
| Pharmacokinetics parameters, including time to maximum concentration and half-time | Baseline through 3 days post administration |
| Pharmacokinetics parameters, including area under concentration-time curves (AUC) | Baseline through 3 days post administration |
Countries
Australia
Outcome results
None listed