A Study of AK0529 in Infants Hospitalized With RSV
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: AK0529 AK0529 pellets |
Drug: AK0529
AK0529 pellets for oral administration
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Number of Adverse Events [Baseline through 7 days post administration]
Secondary Outcome Measures
- 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]
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Women's & Children's Hospital | Adelaide | South Australia | Australia |
Sponsors and Collaborators
- Ark Biosciences Inc.
Investigators
- Study Director: Stephen Toovey, MD PhD, Ark Biosciences Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- AK0529-1002