A Study of AK0529 in Infants Hospitalized With RSV

June 29, 2018 updated by: Ark Biosciences Inc.

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

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • South Australia
      • Adelaide, South Australia, Australia
        • Women's & Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 2 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AK0529
AK0529 pellets
Drug: AK0529
AK0529 pellets for oral administration
Other Names:
  • AK0529 pellets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Adverse Events
Time Frame: Baseline through 7 days post administration
Baseline through 7 days post administration

Secondary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetics parameters, including maximum and minimum of drug concentration
Time Frame: Baseline through 3 days post administration
Baseline through 3 days post administration
Pharmacokinetics parameters, including time to maximum concentration and half-time
Time Frame: Baseline through 3 days post administration
Baseline through 3 days post administration
Pharmacokinetics parameters, including area under concentration-time curves (AUC)
Time Frame: Baseline through 3 days post administration
Baseline through 3 days post administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ark Biosciences Inc.

Investigators

  • Study Director: Stephen Toovey, MD PhD, Ark Biosciences Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 28, 2015

Primary Completion (Actual)

November 3, 2015

Study Completion (Actual)

November 3, 2015

Study Registration Dates

First Submitted

May 27, 2015

First Submitted That Met QC Criteria

May 28, 2015

First Posted (Estimate)

June 2, 2015

Study Record Updates

Last Update Posted (Actual)

July 2, 2018

Last Update Submitted That Met QC Criteria

June 29, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AK0529-1002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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