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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02460016




Registration number
NCT02460016
Ethics application status
Date submitted
27/05/2015
Date registered
2/06/2015
Date last updated
2/07/2018

Titles & IDs
Public title
A Study of AK0529 in Infants Hospitalized With RSV
Scientific 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
Secondary ID [1] 0 0
AK0529-1002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory Syncytial Virus Infections 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AK0529

Experimental: AK0529 - AK0529 pellets


Treatment: Drugs: AK0529
AK0529 pellets for oral administration

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Adverse Events
Timepoint [1] 0 0
Baseline through 7 days post administration
Secondary outcome [1] 0 0
Pharmacokinetics parameters, including maximum and minimum of drug concentration
Timepoint [1] 0 0
Baseline through 3 days post administration
Secondary outcome [2] 0 0
Pharmacokinetics parameters, including time to maximum concentration and half-time
Timepoint [2] 0 0
Baseline through 3 days post administration
Secondary outcome [3] 0 0
Pharmacokinetics parameters, including area under concentration-time curves (AUC)
Timepoint [3] 0 0
Baseline through 3 days post administration

Eligibility
Key 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.
Minimum age
1 Month
Maximum age
24 Months
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Women's & Children's Hospital - Adelaide
Recruitment postcode(s) [1] 0 0
- Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Ark Biosciences Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/show/NCT02460016
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Stephen Toovey, MD PhD
Address 0 0
Ark Biosciences Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02460016