Back to resultsA Study of AK0529 in Infants Hospitalized With RSV
Primary Purpose
Respiratory Syncytial Virus Infections
Status
Terminated
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
AK0529
Sponsored by
About this trial
This is an interventional treatment trial for Respiratory Syncytial Virus Infections
Eligibility 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.
Sites / Locations
- Women's & Children's Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
AK0529
Arm Description
AK0529 pellets
Outcomes
Primary Outcome Measures
Number of Adverse Events
Secondary Outcome Measures
Pharmacokinetics parameters, including maximum and minimum of drug concentration
Pharmacokinetics parameters, including time to maximum concentration and half-time
Pharmacokinetics parameters, including area under concentration-time curves (AUC)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02460016
Brief Title
A Study of AK0529 in Infants Hospitalized With RSV
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Terminated
Why Stopped
We switched this study design to another study per IEC's recommendations.
Study Start Date
August 28, 2015 (Actual)
Primary Completion Date
November 3, 2015 (Actual)
Study Completion Date
November 3, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ark Biosciences Inc.
4. Oversight
Data Monitoring Committee
Yes
5. 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Syncytial Virus Infections
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AK0529
Arm Type
Experimental
Arm Description
AK0529 pellets
Intervention Type
Drug
Intervention Name(s)
AK0529
Other Intervention Name(s)
AK0529 pellets
Intervention Description
AK0529 pellets for oral administration
Primary Outcome Measure Information:
Title
Number of Adverse Events
Time Frame
Baseline through 7 days post administration
Secondary Outcome Measure Information:
Title
Pharmacokinetics parameters, including maximum and minimum of drug concentration
Time Frame
Baseline through 3 days post administration
Title
Pharmacokinetics parameters, including time to maximum concentration and half-time
Time Frame
Baseline through 3 days post administration
Title
Pharmacokinetics parameters, including area under concentration-time curves (AUC)
Time Frame
Baseline through 3 days post administration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Toovey, MD PhD
Organizational Affiliation
Ark Biosciences Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Women's & Children's Hospital
City
Adelaide
State/Province
South Australia
Country
Australia
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study of AK0529 in Infants Hospitalized With RSV
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