A Study of AK0529 in Infants Hospitalized With RSV
- Registration Number
- NCT02460016
- Lead Sponsor
- Shanghai Ark Biopharmaceutical Co., Ltd.
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 1
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description AK0529 AK0529 AK0529 pellets
- Primary Outcome Measures
Name Time Method Number of Adverse Events Baseline through 7 days post administration
- Secondary Outcome Measures
Name Time Method Pharmacokinetics parameters, including time to maximum concentration and half-time Baseline through 3 days post administration Pharmacokinetics parameters, including maximum and minimum of drug concentration Baseline through 3 days post administration Pharmacokinetics parameters, including area under concentration-time curves (AUC) Baseline through 3 days post administration
Trial Locations
- Locations (1)
Women's & Children's Hospital
🇦🇺Adelaide, South Australia, Australia