Clinical trial NCT02460016: 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
Overall status: TERMINATED
Phase: PHASE1
Conditions: Respiratory Syncytial Virus Infections
Lead sponsor: Shanghai Ark Biopharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-06-02
Enrollment: 1
Sex: ALL
Minimum age (years): 1
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Number of Adverse Events
timeFrame: Baseline through 7 days post administration
Secondary outcomes:
measure: Pharmacokinetics parameters, including maximum and minimum of drug concentration
timeFrame: Baseline through 3 days post administration
measure: Pharmacokinetics parameters, including time to maximum concentration and half-time
timeFrame: Baseline through 3 days post administration
measure: Pharmacokinetics parameters, including area under concentration-time curves (AUC)
timeFrame: Baseline through 3 days post administration
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: Women's & Children's Hospital
state: South Australia
Study officials:
affiliation: Shanghai Ark Biopharmaceutical Co., Ltd.
name: Stephen Toovey, MD PhD
role: STUDY_DIRECTOR
References: