Respiratory Syncytial Virus InfectionsPhase 1NCT02460016
A Study of AK0529 in Infants Hospitalized With RSV
A Phase 1 study testing AK0529 in people with Respiratory Syncytial Virus Infections, run by Shanghai Ark Biopharmaceutical Co., Ltd. at 1 site in Australia.
Trial 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). Read more about this study
- Who is it for?
- Ages 1 month to 24 months
- Conditions the study is for
- Respiratory Syncytial Virus Infections
- What is being tested?
- AK0529
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteAustralia
- Study dates
- 28 Aug 2015to 3 Nov 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
Read the 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
- Being tested
- AK0529
- Medical subject headings
- Respiratory Syncytial Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AK0529Drug
Also called AK0529 pellets
AK0529 pellets for oral administration
| Study group | Role | What they receive |
|---|---|---|
| AK0529 | Experimental | AK0529 pellets Receives: Drug: AK0529 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse Events
Measured: Baseline through 7 days post administration
Secondary outcomes (3)
Pharmacokinetics parameters, including maximum and minimum of drug concentration
Measured: Baseline through 3 days post administration
Pharmacokinetics parameters, including time to maximum concentration and half-time
Measured: Baseline through 3 days post administration
Pharmacokinetics parameters, including area under concentration-time curves (AUC)
Measured: Baseline through 3 days post administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2015 (estimated)
- Study start28 Aug 2015
- Primary completion3 Nov 2015
- Study completion3 Nov 2015
Why it stopped: We switched this study design to another study per IEC's recommendations.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Syncytial Virus InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Ark Biopharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stephen Toovey, MD PhD, Study director, Shanghai Ark Biopharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02460016
- Sponsor's protocol ID
- AK0529-1002
- Status last verified
- Jun 2018
- First submitted
- 27 May 2015
- Last updated
- 2 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02460016
- Acronym / sponsor ID
- AK0529-1002
- Conditions
- Respiratory Syncytial Virus Infections
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: We switched this study design to another study per IEC's recommendations.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Shanghai Ark Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Aug 2015 (actual)
- Primary completion
- 3 Nov 2015 (actual)
- Study completion
- 3 Nov 2015 (actual)
- First posted
- 2 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AK0529 | Experimental | Drug: AK0529AK0529 pellets |
Who may qualify
- Ages
- 1 month to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AK0529Also: AK0529 pelletsAK0529 pellets for oral administration | Drug | AK0529 |
Primary outcome
Number of Adverse Events
Time frame: Baseline through 7 days post administration
3 secondary outcomes
Pharmacokinetics parameters, including maximum and minimum of drug concentration
Time frame: Baseline through 3 days post administration
Pharmacokinetics parameters, including time to maximum concentration and half-time
Time frame: Baseline through 3 days post administration
Pharmacokinetics parameters, including area under concentration-time curves (AUC)
Time frame: Baseline through 3 days post administration
Results and safety
The study was stopped early (reason given: We switched this study design to another study per IEC's recommendations.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2018.
- Individual participant dataSharing planned: No
Related trials for Respiratory Syncytial Virus Infections
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Toovey, MD PhD study director
Shanghai Ark Biopharmaceutical Co., Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AK0529 in people with Respiratory Syncytial Virus Infections, run by Shanghai Ark Biopharmaceutical Co., Ltd. at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: We switched this study design to another study per IEC's recommendations.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Adverse Events (time frame: Baseline through 7 days post administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2018.