A Study of AK0529 in Infants Hospitalized With RSV

• Status: Terminated
• Trial end date: 2015-11-03
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ark Biosciences Inc.
• Treatments: Ziresovir

Criteria

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.