A Study of AK0529 in Infants Hospitalized With RSV

NCT02460016 | Terminated Phase 1 DMC

• 1 other identifier: AK0529-1002
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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).

Conditions

Respiratory Syncytial Virus Infections

Outcome Measures

Primary Outcomes (1)

• Number of Adverse Events

  Baseline through 7 days post administration

Secondary Outcomes (3)

• Pharmacokinetics parameters, including maximum and minimum of drug concentration

  Baseline through 3 days post administration

• Pharmacokinetics parameters, including time to maximum concentration and half-time

  Baseline through 3 days post administration

• Pharmacokinetics parameters, including area under concentration-time curves (AUC)

  Baseline through 3 days post administration

Study Arms (1)

AK0529

EXPERIMENTAL

AK0529 pellets

Drug: AK0529

Interventions

AK0529 DRUG

AK0529 pellets for oral administration

Also known as: AK0529 pellets

AK0529

Eligibility Criteria

• Age: 1 Month - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Ark Biopharmaceutical Co., Ltd.: lead

Study Sites (1)

Women's & Children's Hospital

Adelaide, South Australia, Australia

Location

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Interventions

ziresovir

Condition Hierarchy (Ancestors)

Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Study Officials

• Stephen Toovey, MD PhD

  Shanghai Ark Biopharmaceutical Co., Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2015
• First Posted: June 2, 2015
• Study Start: August 28, 2015
• Primary Completion: November 3, 2015
• Study Completion: November 3, 2015
• Last Updated: July 2, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)