A Study of AK0529 in Infants Hospitalized With RSV

NCT ID: NCT02460016

Last Updated: 2018-07-02

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-28
• Study Completion Date: 2015-11-03

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.

Conditions

Respiratory Syncytial Virus Infections

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AK0529

AK0529 pellets

Group Type: EXPERIMENTAL

AK0529

Intervention Type: DRUG

AK0529 pellets for oral administration

Interventions

AK0529

AK0529 pellets for oral administration

Intervention Type: DRUG

Other Intervention Names

AK0529 pellets

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.

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 24 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Ark Biopharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephen Toovey, MD PhD

Role: STUDY_DIRECTOR

Shanghai Ark Biopharmaceutical Co., Ltd.

Locations

Women's & Children's Hospital

Adelaide, South Australia, Australia

Countries

Australia

Other Identifiers

AK0529-1002

Identifier Type: -

Identifier Source: org_study_id