Phase 1 study for people with Focal Segmental Glomerulosclerosis
Recruiting Phase 1
This trial at a glance
Where this trial is running
| Site | City | State or country | Status at this site |
|---|---|---|---|
| Q-Pharm Pty Ltd. | Herston | QLD | Recruiting |
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:
1. Healthy male and female participants aged 18 to 55 years (inclusive) at the time of screening.
2. Weight and BMI for female and male participants:
Body weight ≥ 50 kg; Body mass index (BMI) between 18.5 and 29.9 kg/m2 (inclusive)
3. Participants must be in good general health.
4. Capable of understanding and voluntarily providing written informed consent prior to any study-related procedures.
5. Participants must have no plans for conception during the trial and for 3 months after the last dose, and must voluntarily use effective contraception with no plans for sperm or egg donation .
Exclusion Criteria:
1. History or current presence of clinically significant Cardiovascular; Respiratory ; Gastrointestinal; Neurological ; Hematologic/immunologic disorders.
2. Chronic GI conditions requiring daily medication; or history of bariatric surgery.
3. Live/attenuated vaccines within 4 weeks prior to dosing or planned during study.
4. Systolic blood pressure \< 90 mmHg or ≥ 140 mmHg, or diastolic blood pressure ≥80 mmHg.
5. History of myocardial infarction, angina, coronary artery bypass grafting, angioplasty, stenting, congestive heart failure, uncontrolled hypotension, unexplained arrhythmia, ventricular tachycardia, atrioventricular block, QT prolongation syndrome, or symptoms/family history of QT prolongation syndrome, as assessed by the investigator to be unsuitable for participation.
6. Positive results for hepatitis B surface antigen, syphilis-specific antibodies, hepatitis C antibodies, or HIV antibodies.
7. Major surgery or trauma requiring hospitalization within 6 months.
8. Hypersensitivity to any component of SK-09 or its excipients.
9. Poor venous access or needle phobia impacting study procedures.
10. History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months.
11. Current smokers unwilling to abstain during study.
12. Participants with ANY of the following abnormalities in clinical laboratory tests at screening and confirmed by a single repeat test, if deemed necessary:
* AST or ALT level ≥ 1.5×ULN;
* Total bilirubin level ≥ 1.5×ULN (except Gilbert's with direct bilirubin ≤ ULN)
13. Blood loss or donation exceeding 400 mL within 3 months of dosing.
14. Other investigational product within 30 days of dosing or 5 half-lives (whichever longer).
15. Use of any medications, including over-the-counter drugs, herbal medicine, vitamins, and health supplements, within 2 weeks prior to the first dose or 5 half-lives (whichever longer).
16. Positive pregnancy test or breastfeeding.
17. Unprotected sexual activity within 2 weeks prior to the first dose.
18. Any condition that, in the investigator's opinion, may pose a safety risk to the participant, interfere with the study, or prevent the participant from completing the study or complying with its requirements (due to administrative or other reasons).
19. Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.
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: 3 September 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.