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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/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
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases
Respiratory 0 0 0 0
Other respiratory disorders / diseases

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
Sex
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
N/A
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
28/08/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
3/11/2015
Sample size
Target
Accrual to date
Final
1
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
Shanghai Ark Biopharmaceutical Co., Ltd.
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/ct2/show/NCT02460016
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Stephen Toovey, MD PhD
Address 0 0
Shanghai Ark Biopharmaceutical Co., Ltd.
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/ct2/show/NCT02460016