Respiratory Syncytial Virus InfectionsPhase 1NCT02297594
Safety, Tolerability and PK Study of AK0529 in Healthy Human
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
The purpose of this study is to assess the safety, tolerability and PK of single and multiple ascending dose of AK0529 when administered orally in healthy subjects Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- 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?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteAustralia
- Study dates
- Oct 2014to Jun 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Must be healthy males, or healthy females of non-childbearing potential or surgically sterilized or post-menopausal (amenorrhea for at least 1 year and confirmed by a follicle stimulating hormone [FSH] result of > 20 IU/mL).
- Must be aged 18 to 55 years of age inclusive.
- Must have body mass index (BMI) of 18.0 to 31.0 kg/m2 inclusive.
- Must have total body weight ≥50 kg at screening but ≤100 Kg.
- Must be willing and able to communicate and participate in the whole study.
- Must provide written informed consent.
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- Must agree to use an adequate method of contraception (as defined in Section 4.2.1).
- Must have AST, ALT, total bilirubin, urea, creatinine and hemoglobin within the laboratory reference range at screening and Day -1.
- Must have QTcF <450 ms, QTcB <450 ms and PR interval <210 ms for screening, Day -1 and pre-dose ECG measurements, and not have any degree of heart block or conduction abnormality.
- Must have serology demonstrating they are free from infection with hepatitis B, hepatitis C, and human immunodeficiency virus (HIV-1 and HIV-2)
Who cannot join
- Male subjects who have currently pregnant partners or who have partners planning to become pregnant during the duration of the study.
- Evidence or history of clinical significant oncological, pulmonary, chronic respiratory, hepatic, cardiovascular, hematological, metabolic, neurological, immunological, nephrological, endocrine or psychiatric disease, or current infection.
- Clinically relevant (as decided by the investigator and the medical monitor) abnormalities in the ECG (12 standard leads) including any degree of heart block, including asymptomatic bundle branch block.
- Family history of sudden death or of congenital prolongation of the QTc interval or known congenital prolongation of the QTc interval or any clinical condition known to prolong the QTc interval.
- History of symptomatic cardiac arrhythmias or with clinically relevant bradycardia.
- Electrolyte disturbances, particularly hypokalemia hypocalcemia or hypomagnesemia.
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- Any condition that could possibly affect drug absorption, e.g. gastrectomy or diarrhea.
- History of post-antibiotic colitis.
- History of any drug or alcohol abuse in the past 2 years prior to screening.
- Regular alcohol consumption in males >21 units per week and females >14 units per week (1 unit = 400 mL beer, 25 mL of 40% spirit or a 75 mL glass of wine).
- Subjects who have a urine cotinine greater than 500 ng/mL at screening will be excluded. Subjects who are tobacco users (including smokers and users of snuff, chewing tobacco and other nicotine or nicotine-containing products) must have stopped use at least 90 days before screening.
- Receipt of an investigational drug or participation in another clinical research study within 90 days prior to drug administration.
- Subjects who are study site employees, or immediate family members of a study site or sponsor employee.
- Subjects who have previously been enrolled and dosed in this study, except subjects undergoing repeat dosing in Cohort 4F (the fed PK cohort of the SAD part of the study).
- Other protocol defined inclusion/exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
Australia1 site
Q-Pharm Pty Ltd QIMR Berghofer & Royal Brisbane and Women's Hospital Campus
Brisbane, Queensland, 4006
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of AK0529 When Administered Orally in Healthy Male and Female Adult Subjects
The purpose of this study is to assess the safety, tolerability and PK of single and multiple ascending dose of AK0529 when administered orally in healthy subjects
Read the detailed description
This is a Phase 1, first-in-man, single-center, randomized, double blind, placebo controlled single and multiple ascending dose study in healthy male and female volunteers.
- Conditions
- Respiratory Syncytial Virus Infections
- Being tested
- AK0529, Placebo
- 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 capsule
AK0529 capsule for oral administration
PlaceboDrug
Also called Sugar placebo capsule
Sugar placebo capsule for oral administration
| Study group | Role | What they receive |
|---|---|---|
| AK0529 | Experimental | Generic name: AK0529 Dosage Form: capsule Receives: Drug: AK0529 |
| Placebo | Placebo comparator | Sugar placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events, serious adverse events
Measured: Screening to Day 14 - 21
Secondary outcomes (12)
Pharmacokinetics of single dose study: Area Under Curve (AUC)
Measured: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hours post-dose
Pharmacokinetics of single dose study: Observed Maximum plasma concentration (Cmax)
Measured: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hours post-dose
Pharmacokinetics of single dose study: half-life (t1/2)
Measured: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hours post-dose
Pharmacokinetics of single dose study: time to maximum plasma concentration (tmax)
Measured: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hours post-dose
Pharmacokinetics of single dose study: Volume of distribution
Measured: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hours post-dose
Pharmacokinetics of single dose study: Clearance
Measured: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hours post-dose
Pharmacokinetics of multiple dose study:Area Under Curve (AUC)
Measured: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8 and 12 hours post-dose on Day1 and pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 hours post-dose on Day 7 and at 24 hours (Day 8) and at 48 hours (Day 9)
Pharmacokinetics of multiple dose study: Observed Maximum plasma concentration (Cmax)
Measured: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8 and 12 hours post-dose on Day1 and pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 hours post-dose on Day 7 and at 24 hours (Day 8) and at 48 hours (Day 9)
Pharmacokinetics of multiple dose study: half-life (t1/2)
Measured: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8 and 12 hours post-dose on Day1 and pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 hours post-dose on Day 7 and at 24 hours (Day 8) and at 48 hours (Day 9)
Pharmacokinetics of multiple dose study: time to maximum plasma concentration (tmax)
Measured: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8 and 12 hours post-dose on Day1 and pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 hours post-dose on Day 7 and at 24 hours (Day 8) and at 48 hours (Day 9)
Pharmacokinetics of multiple dose study:Volume of distribution
Measured: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8 and 12 hours post-dose on Day1 and pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 hours post-dose on Day 7 and at 24 hours (Day 8) and at 48 hours (Day 9)
Pharmacokinetics of multiple dose study: clearance
Measured: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8 and 12 hours post-dose on Day1 and pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 hours post-dose on Day 7 and at 24 hours (Day 8) and at 48 hours (Day 9)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2014 (estimated)
- Study startOct 2014
- Primary completionJun 2015
- Study completionJun 2015
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Ark Biopharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paul Griffin, MD, Principal investigator, Q-Pharm Pty Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02297594
- Sponsor's protocol ID
- AK0529-1001
- Status last verified
- Oct 2015
- First submitted
- 11 Nov 2014
- Last updated
- 20 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of AK0529 When Administered Orally in Healthy Male and Female Adult Subjects
- ClinicalTrials.gov ID
- NCT02297594
- Acronym / sponsor ID
- AK0529-1001
- Conditions
- Respiratory Syncytial Virus Infections
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Shanghai Ark Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 21 Nov 2014 (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.
The purpose of this study is to assess the safety, tolerability and PK of single and multiple ascending dose of AK0529 when administered orally in healthy subjects
Detailed description
This is a Phase 1, first-in-man, single-center, randomized, double blind, placebo controlled single and multiple ascending dose study in healthy male and female volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AK0529 | Experimental | Drug: AK0529Generic name: AK0529 Dosage Form: capsule |
| Placebo | Placebo comparator | Drug: PlaceboSugar placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Must be healthy males, or healthy females of non-childbearing potential or surgically sterilized or post-menopausal (amenorrhea for at least 1 year and confirmed by a follicle stimulating hormone [FSH] result of > 20 IU/mL).
- Must be aged 18 to 55 years of age inclusive.
- Must have body mass index (BMI) of 18.0 to 31.0 kg/m2 inclusive.
- Must have total body weight ≥50 kg at screening but ≤100 Kg.
- Must be willing and able to communicate and participate in the whole study.
Key exclusion criteria (15 listed)
- Male subjects who have currently pregnant partners or who have partners planning to become pregnant during the duration of the study.
- Evidence or history of clinical significant oncological, pulmonary, chronic respiratory, hepatic, cardiovascular, hematological, metabolic, neurological, immunological, nephrological, endocrine or psychiatric disease, or current infection.
- Clinically relevant (as decided by the investigator and the medical monitor) abnormalities in the ECG (12 standard leads) including any degree of heart block, including asymptomatic bundle branch block.
- Family history of sudden death or of congenital prolongation of the QTc interval or known congenital prolongation of the QTc interval or any clinical condition known to prolong the QTc interval.
- History of symptomatic cardiac arrhythmias or with clinically relevant bradycardia.
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 capsuleAK0529 capsule for oral administration | Drug | AK0529 |
| PlaceboAlso: Sugar placebo capsuleSugar placebo capsule for oral administration | Drug | Placebo |
Primary outcome
Number of participants with adverse events, serious adverse events
Time frame: Screening to Day 14 - 21
12 secondary outcomes
Pharmacokinetics of single dose study: Area Under Curve (AUC)
Time frame: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hours post-dose
Pharmacokinetics of single dose study: Observed Maximum plasma concentration (Cmax)
Time frame: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hours post-dose
Pharmacokinetics of single dose study: half-life (t1/2)
Time frame: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hours post-dose
Pharmacokinetics of single dose study: time to maximum plasma concentration (tmax)
Time frame: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hours post-dose
Pharmacokinetics of single dose study: Volume of distribution
Time frame: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hours post-dose
Pharmacokinetics of single dose study: Clearance
Time frame: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hours post-dose
Pharmacokinetics of multiple dose study:Area Under Curve (AUC)
Time frame: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8 and 12 hours post-dose on Day1 and pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 hours post-dose on Day 7 and at 24 hours (Day 8) and at 48 hours (Day 9)
Pharmacokinetics of multiple dose study: Observed Maximum plasma concentration (Cmax)
Time frame: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8 and 12 hours post-dose on Day1 and pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 hours post-dose on Day 7 and at 24 hours (Day 8) and at 48 hours (Day 9)
Pharmacokinetics of multiple dose study: half-life (t1/2)
Time frame: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8 and 12 hours post-dose on Day1 and pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 hours post-dose on Day 7 and at 24 hours (Day 8) and at 48 hours (Day 9)
Pharmacokinetics of multiple dose study: time to maximum plasma concentration (tmax)
Time frame: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8 and 12 hours post-dose on Day1 and pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 hours post-dose on Day 7 and at 24 hours (Day 8) and at 48 hours (Day 9)
Pharmacokinetics of multiple dose study:Volume of distribution
Time frame: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8 and 12 hours post-dose on Day1 and pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 hours post-dose on Day 7 and at 24 hours (Day 8) and at 48 hours (Day 9)
Pharmacokinetics of multiple dose study: clearance
Time frame: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8 and 12 hours post-dose on Day1 and pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 hours post-dose on Day 7 and at 24 hours (Day 8) and at 48 hours (Day 9)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2015.
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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.
Paul Griffin, MD principal investigator
Q-Pharm Pty 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 10 inclusion and 15 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: finished, as of the sponsor's last update on 20 Oct 2015. 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. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 participants with adverse events, serious adverse events (time frame: Screening to Day 14 - 21). 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 20 Oct 2015.