Phase 1 study
Not yet recruiting Phase 1
This trial at a glance
Where this trial is running
| Site | City | State or country | Status at this site |
|---|---|---|---|
| Veritus Research | Bayswater | VIC | Status not stated |
voxsanity.com.au · trial sites from public registries · registry record synced 11 October 2026 · not medical advice
Who can join
The official eligibility criteria
Registry text, reproduced exactly. These are the words the trial's sponsor published on ClinicalTrials.gov. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.
Inclusion Criteria:
* Male or female participants aged 18 to 65 years (inclusive) at the time of formed consent.
* At screening, male participants must weigh ≥50 kilogram (kg), and female participants must weigh ≥45 kg, with a body mass index between 18.0 and 32.0 kilograms per square meter (kg/m²) (inclusive).
* Participants must be in good general health as determined by the investigator, with no clinically significant abnormalities in vital signs, 12-lead electrocardiogram (ECG), or laboratory tests.
* Woman of childbearing potential (WOCBP) and male participants whose female sexual partner is WOCBP must agree to use highly effective contraception from the day of study drug administration until 6 months after dosing and must agree to avoid sperm or oocyte donation and not plan to conceive during this period.
* Participants must voluntarily agree to participate, be able to communicate effectively with the investigator, understand and comply with study requirements, and provide written informed consent.
Exclusion Criteria:
* Presence of clinically significant cardiovascular, respiratory, hepatic, renal, hematologic (e.g., bleeding disorders), gastrointestinal, endocrine, immune, dermatologic, neurologic, or psychiatric disease, or any other condition that, in the opinion of the investigator, may compromise participant safety, interfere with study results, or prevent completion of the study.
* Active malignancy or history of malignancy (except adequately treated basal cell carcinoma with no evidence of recurrence).
* History of congenital or acquired immunodeficiency.
* Acute illness (e.g., fever, infectious disease, diarrhea) within 7 days prior to first dosing.
* Major surgery within 3 months before screening or planned major surgery within 6 months after study drug administration.
* Known hypersensitivity to neuraminidase inhibitors (e.g., oseltamivir, zanamivir, peramivir), or to AK0406 active ingredient or any excipients.
* Anaphylaxis or severe hypersensitivity (e.g., hypotension, dyspnea, severe angioedema).
Diagnostic Assessments
* Positive for Human immunodeficiency virus (HIV) antibody, Hepatitis C virus (HCV) antibody, Hepatitis B surface antigen (HBsAg), or Treponema pallidum antibody.
* Systolic blood pressure \>140 millimeters of mercury (mmHg) or ≤90 mmHg, diastolic blood pressure ≥90 mmHg or ≤50 mmHg, or pulse ≤45 or ≥110 beats per minute (bpm) while awake and at rest.
* The Corrected QT interval by Fredericia (QTcF) prolongation (up to 450 ms in males / 470 milliseconds (ms) in females) at screening. \[QTcF = QT/(RR\^0.33)\] (RR = 60/heart rate)
Dates on the record
Results, publications and the official record
- No results are posted on the official record yet.
- No publications are listed on the official record yet.
- Official record and contacts on ClinicalTrials.gov – contact details for each site are kept there, and are not copied onto this page.
Sources and dates
- ClinicalTrials.gov – the record this page reformats
- ClinicalTrials.gov processing date: 25 February 2026.
- This page last checked by Voxsanity: 11 October 2026.
Voxsanity reformats data from public registries into this layout. It does not edit, interpret or add to what the registry published.
Not medical advice.
Individual trial records are refreshed on a rolling basis rather than all at once, so a record may be up to several weeks old. Each trial page and trial card shows the date its own record was last synced. Where a record has lagged, its status, sites and enrolment can differ from the current registry state in either direction, so check the registry link on the trial page before acting on them.
Letter for your doctor
A one-page summary of this trial to print or email to your GP. It carries the registry's own record of the trial and its eligibility criteria, and nothing Voxsanity has written about whether it suits you.