Clinical Trials List
Protocol NumberAK0529-1003
2016-05-01 - 2018-12-31
Phase II
Terminated4
ICD-10B97.4
Respiratory syncytial virus as the cause of diseases classified elsewhere
ICD-9079.6
Respiratory syncytial virus(RSV) infections in conditions classified elsewhere and of unspecified site
A Randomised, Double-blind, Placebo-controlled, 2-Part Study of Orally Administered AK0529 to Evaluate the Safety, Tolerability, Pharmacokinetics and Antiviral Effect of Single and Multiple Dosing in Hospitalised Infants with Respiratory Syncytial Virus Infection
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Trial Applicant
TAIWAN TIGERMED CONSULTING CO
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Sponsor
Ark Biosciences Pty Ltd
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- 丁瑋信 Division of Pediatrics
- 江椿彬 Division of Pediatrics
- Nan-Chang Chiu Division of Pediatrics
- Daniel Tsung-Ning Huang Division of Pediatrics
- 黃競瑩 Division of Pediatrics
The Actual Total Number of Participants Enrolled
0 Stop recruiting
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- Luan-Yin Chang Division of Pediatrics
- 楊宗儒 Division of Pediatrics
- Chun-yi Lu Division of Pediatrics
- 林谷龍 Division of Pediatrics
- 呂立 Division of Pediatrics
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Audit
None
Co-Principal Investigator
- 江椿彬 Division of Pediatrics
- 黃競瑩 Division of Pediatrics
- 丁瑋信 Division of Pediatrics
- Nan-Chang Chiu Division of Pediatrics
- Daniel Tsung-Ning Huang Division of Pediatrics
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Condition/Disease
Respiratory Syncytial Virus (RSV) Infection
Objectives
Primary ObjectiveThe primary objective is:• To evaluate the safety and tolerability of single and multiple oral doses of AK0529in infants hospitalised with RSVSecondary ObjectivesThe secondary objectives are:• To characterise the single and multiple dose pharmacokinetics of AK0529 ininfants hospitalised with RSV• To determine the antiviral effects in infants hospitalised with RSV by measuringthe RSV viral load (VL) area under the curve (AUCElast) in nasal, pharyngeal andtracheal washes / aspirates• To evaluate the clinical benefit of AK0529 by determination of the RSV RelatedSigns and Symptom Scores of infants hospitalised with RSV; additional clinicalendpoints will be assessed including:- Time to return to participation in usual activitiesExploratory ObjectivesThe exploratory objectives are:• To evaluate the pharmacokinetic and pharmacodynamic (PK-PD) relationshipbetween PK and VL after repeated oral dosing• To explore the profile of AK0529 metabolites in infants hospitalised with RSV• To determine RSV genotype and genomic sequence of RSV clinical isolates fromrespiratory tract specimens; assessment of emergence of AK0529 drug resistantmutation
Test Drug
AK0529
Active Ingredient
C24H23NO5S
Dosage Form
capsule
Dosage
100
Endpoints
Primary Outcome Measures
• Safety and tolerability parameters will be assessed:
- Laboratory tests (haematology, chemistry, and urinalysis test results), and
changes from Baseline in these parameters, at each predefined time point
- ECG measures summarised by the observed data and changes from Baseline in
these parameters, at pre-defined time points
- vital sign parameters (systolic and diastolic blood pressure, temperature,
respiration rate, and heart rate), and changes from Baseline in these parameters,
at predefined time points
- Incidence of AEs, serious AEs (SAEs), and withdrawals due to AEs
• Safety and tolerability parameters will be assessed:
- Laboratory tests (haematology, chemistry, and urinalysis test results), and
changes from Baseline in these parameters, at each predefined time point
- ECG measures summarised by the observed data and changes from Baseline in
these parameters, at pre-defined time points
- vital sign parameters (systolic and diastolic blood pressure, temperature,
respiration rate, and heart rate), and changes from Baseline in these parameters,
at predefined time points
- Incidence of AEs, serious AEs (SAEs), and withdrawals due to AEs
Inclution Criteria
Inclusion Criteria
Patients must meet all of the following criteria:
1. Male or female patients of any race or ethnicity with an age adjusted for any
prematurity [10] of ≥1 month and ≤24 months.
2. Diagnosis of RSV infection by virological means, which may include rapid
diagnostic point of care testing, within 96 hours preceding screening for Part 1 and 72
hours for Part 2.
3. Patient must weigh >3 kg at screening and be within the 10th and 90th percentiles
(inclusive) for the patient’s age, based on the local child growth standards, i.e. the
Australian Paediatric Endocrine Group Growth Charts [11].
4. The parent / legal guardian of the patient must have provided written informed
consent for the patient to participate.
5. For patients aged <12 months, and occipito-frontal head circumference (OFHC)
within the normal range for age and gender.
Patients must meet all of the following criteria:
1. Male or female patients of any race or ethnicity with an age adjusted for any
prematurity [10] of ≥1 month and ≤24 months.
2. Diagnosis of RSV infection by virological means, which may include rapid
diagnostic point of care testing, within 96 hours preceding screening for Part 1 and 72
hours for Part 2.
3. Patient must weigh >3 kg at screening and be within the 10th and 90th percentiles
(inclusive) for the patient’s age, based on the local child growth standards, i.e. the
Australian Paediatric Endocrine Group Growth Charts [11].
4. The parent / legal guardian of the patient must have provided written informed
consent for the patient to participate.
5. For patients aged <12 months, and occipito-frontal head circumference (OFHC)
within the normal range for age and gender.
Exclusion Criteria
Exclusion Criteria
Patients meeting any of the following criteria will be excluded from participating in the
study:
1. The patient has taken, is currently taking or requires any restricted medications.
2. Patient is known to be HIV-positive (or the mother, if the potential patient is a child
aged <6 months).
3. Participation in an investigational drug or device study within 30 days prior to the
date of screening.
4. Requires vasopressors or inotropic support at the time of enrolment.
5. 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).
6. Bronchopulmonary dysplasia or chronic lung disease requiring assisted ventilation
at the time of enrolment.
7. Diminished ventilatory reserve at risk for hypercapnia (e.g. pulmonary hypoplasia,
sequestration syndromes, cystadenomatoid malformation, a history of surgery for
diaphragmatic hernia).
8. Left to right shunt meriting corrective therapy.
9. Renal failure including renal anomalies likely to be associated with renal
insufficiency (e.g. clinical conditions of renal dysplasia, polycystic renal disease,
renal agenesis).
10. Clinical evidence of hepatic decompensation e.g. hepatic disorder with associated
coagulopathy or associated encephalopathy).
11. Cerebral palsy with microcephaly, chronic or persistent feeding difficulties or
seizures.
12. Symptomatic because of inborn errors of metabolism (e.g. mitochondrial disorders,
disorders of carbohydrate metabolism, glycogen storage disorders).
13. Congenital or acquired immunodeficiency (e.g. congenital agammaglobulinaemia,
common variable immunodeficiency, immunosuppressive therapy other than
glucocorticoid or monteleukast therapy forming part of care directed by the treating
physician).
14. For Part 2 of this study, children with a history of having received palivizumab or
any other monoclonal agent directed against RSV in the preceding 120 days. This
exclusion criterion does not apply to Part 1.
15. Evidence of active or uncontrolled respiratory, cardiac, hepatic, central nervous
system or renal disease unrelated to RSV infection at baseline or any other medical
condition that in the opinion of the investigator renders the patient unsuitable for
enrolment.
16. A history of epilepsy or seizures including febrile seizures.
17. Allergy to test medication or constituents.
18. Weight less than 10th percentile or greater than 90th percentile for age and gender
adjusted for any prematurity.
19. The patient’s parent or legally acceptable representative is an employee of the
investigator or the study center, with direct involvement in the proposed study or
other studies under the direction of that investigator of the study center, or any
family members of the employees or the investigator.
20. Failure to satisfy the investigator of fitness to participate for any other reason.
Patients who do not meet the eligibility criteria should not be enrolled into the study,
without exception. In case of doubt, the investigator is to confer with the medical
monitor for agreement.
Patients meeting any of the following criteria will be excluded from participating in the
study:
1. The patient has taken, is currently taking or requires any restricted medications.
2. Patient is known to be HIV-positive (or the mother, if the potential patient is a child
aged <6 months).
3. Participation in an investigational drug or device study within 30 days prior to the
date of screening.
4. Requires vasopressors or inotropic support at the time of enrolment.
5. 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).
6. Bronchopulmonary dysplasia or chronic lung disease requiring assisted ventilation
at the time of enrolment.
7. Diminished ventilatory reserve at risk for hypercapnia (e.g. pulmonary hypoplasia,
sequestration syndromes, cystadenomatoid malformation, a history of surgery for
diaphragmatic hernia).
8. Left to right shunt meriting corrective therapy.
9. Renal failure including renal anomalies likely to be associated with renal
insufficiency (e.g. clinical conditions of renal dysplasia, polycystic renal disease,
renal agenesis).
10. Clinical evidence of hepatic decompensation e.g. hepatic disorder with associated
coagulopathy or associated encephalopathy).
11. Cerebral palsy with microcephaly, chronic or persistent feeding difficulties or
seizures.
12. Symptomatic because of inborn errors of metabolism (e.g. mitochondrial disorders,
disorders of carbohydrate metabolism, glycogen storage disorders).
13. Congenital or acquired immunodeficiency (e.g. congenital agammaglobulinaemia,
common variable immunodeficiency, immunosuppressive therapy other than
glucocorticoid or monteleukast therapy forming part of care directed by the treating
physician).
14. For Part 2 of this study, children with a history of having received palivizumab or
any other monoclonal agent directed against RSV in the preceding 120 days. This
exclusion criterion does not apply to Part 1.
15. Evidence of active or uncontrolled respiratory, cardiac, hepatic, central nervous
system or renal disease unrelated to RSV infection at baseline or any other medical
condition that in the opinion of the investigator renders the patient unsuitable for
enrolment.
16. A history of epilepsy or seizures including febrile seizures.
17. Allergy to test medication or constituents.
18. Weight less than 10th percentile or greater than 90th percentile for age and gender
adjusted for any prematurity.
19. The patient’s parent or legally acceptable representative is an employee of the
investigator or the study center, with direct involvement in the proposed study or
other studies under the direction of that investigator of the study center, or any
family members of the employees or the investigator.
20. Failure to satisfy the investigator of fitness to participate for any other reason.
Patients who do not meet the eligibility criteria should not be enrolled into the study,
without exception. In case of doubt, the investigator is to confer with the medical
monitor for agreement.
The Estimated Number of Participants
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Taiwan
50 participants
-
Global
80 participants
