A Study of AK0529 in Infants Hospitalized With RSV

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase 1b, Open-label, Multicenter, Single Dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of AK0529 in Infants Hospitalized With Respiratory Syncytial Virus Infection

Conditions
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Respiratory Syncytial Virus Infections

Intervention / Treatment
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* Drug: AK0529


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 24 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AK0529<br>AK0529 pellets | Drug: AK0529<br>* AK0529 pellets for oral administration<br>* Other names: AK0529 pellets;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Adverse Events |  | Baseline through 7 days post administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |