FSGSPhase 1NCT07267026
A Study to Evaluate the Safety, Tolerability and PK of SK-09
A Phase 1 study testing SK-09 in people with FSGS and MCD, run by Consun Pharmaceutical Group at 1 site in Australia.
Trial summary
This Phase 1 trial consists of three parts: Part 1 is a Single Ascending Dose (SAD) study, Part 2 is a Multiple Ascending Dose (MAD) study. Both parts adopt a randomized, double-blind, placebo-controlled design. Part 3 is a randomized, open-label, single-dose, two-period crossover self-controlled design FE study. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- What is being tested?
- SK-09
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteAustralia
- Study dates
- 8 Dec 2025to 30 Apr 2027
- Phase
- Phase 1
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
- Healthy male and female participants aged 18 to 55 years (inclusive) at the time of screening.
- 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)
- Participants must be in good general health.
- Capable of understanding and voluntarily providing written informed consent prior to any study-related procedures.
- 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 .
Who cannot join
- History or current presence of clinically significant Cardiovascular; Respiratory ; Gastrointestinal; Neurological ; Hematologic/immunologic disorders.
- Chronic GI conditions requiring daily medication; or history of bariatric surgery.
- Live/attenuated vaccines within 4 weeks prior to dosing or planned during study.
- Systolic blood pressure < 90 mmHg or ≥ 140 mmHg, or diastolic blood pressure ≥80 mmHg.
- 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.
- Positive results for hepatitis B surface antigen, syphilis-specific antibodies, hepatitis C antibodies, or HIV antibodies.
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- Major surgery or trauma requiring hospitalization within 6 months.
- Hypersensitivity to any component of SK-09 or its excipients.
- Poor venous access or needle phobia impacting study procedures.
- History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months.
- Current smokers unwilling to abstain during study.
- 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)
- Blood loss or donation exceeding 400 mL within 3 months of dosing.
- Other investigational product within 30 days of dosing or 5 half-lives (whichever longer).
- 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).
- Positive pregnancy test or breastfeeding.
- Unprotected sexual activity within 2 weeks prior to the first dose.
- 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).
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
Q-Pharm Pty Ltd.
Herston, Queensland
Teena Pisarev Chief Executive Officer, 0737072720, g.wong@nucleusnetwork.com.au
Gloria Yee Man Wong, Doctor
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, First-In-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Oral Doses of SK-09 in Healthy Adult Participants
This Phase 1 trial consists of three parts: Part 1 is a Single Ascending Dose (SAD) study, Part 2 is a Multiple Ascending Dose (MAD) study. Both parts adopt a randomized, double-blind, placebo-controlled design. Part 3 is a randomized, open-label, single-dose, two-period crossover self-controlled design FE study.
Read the detailed description
Part 1 is a randomized, double-blind, placebo-controlled SAD study to evaluate the safety, tolerability, PK, and PD of single oral doses of SK-09 tablets in healthy adult participants.
Part 2 is a randomized, double-blind, placebo-controlled MAD study designed to evaluate the safety, tolerability, PK, and PD of multiple oral doses of SK-09 tablets in healthy adult participants.
Part 3 is a randomized, open-label, single-dose, two-period crossover self-controlled design FE study to evaluate the food effect on safety, tolerability, and PK of single oral doses of SK-09 tablets in healthy adult participants.
- Being tested
- SK-09, Placebo
- Medical subject headings
- Macular dystrophy, corneal type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SK-09Drug
SAD:Dose groups of 20 mg, 50 mg, 100 mg, 200 mg, 400 mg, and 500 mg were given.
MAD：Dose groups (low100 mg BID, 200 mg BID, and 500mg QD or 300mg BID/medium/high, based on Part 1 SAD results) will be given.
FE：Dose group (150mg) was given.
PlaceboDrug
SAD：Dose groups of 20 mg, 50 mg, 100 mg, 200 mg, 400 mg, and 500 mg were given.
MAD：Dose groups (low100 mg BID, 200 mg BID, and 500mg QD or 300mg BID/medium/high, based on Part 1 SAD results) were given.
| Study group | Role | What they receive |
|---|---|---|
| SK-09 | Experimental | Part 1 SAD：Six sequential dose groups will be evaluated, with the planned dose levels as follows: 20 mg, 50 mg, 100 mg, 200 mg, 400 mg, and 500 mg.
Part 2 MAD：Three planned dose groups (low100 mg BID, 200 mg BID, and 500mg QD or 300mg BID/medium/high, based on Part 1 SAD results) will be sequentially evaluated.
Part 3 FE：One planned dose group (150 mg ), 12 participants will be randomized 1:1 to two sequences (Seq 1: AB; Seq 2: BA). Receives: Drug: SK-09 |
| Placebo | Placebo comparator | Part 1 SAD：Six sequential dose groups will be evaluated, with the planned dose levels as follows: 20 mg, 50 mg, 100 mg, 200 mg, 400 mg, and 500 mg.
Part 2 MAD：Three planned dose groups (low100 mg BID, 200 mg BID, and 500mg QD or 300mg BID/medium/high, based on Part 1 SAD results) will be sequentially evaluated. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Evaluation
Number of participants with AE, with abnormal Vital Signs, abnormal Physical Examination findings, abnormal Laboratory Tests results, abnormal 12-lead ECG readings
Measured: up to 8 days post-dosing for SAD ，up to 14 days post-dosing for MAD， up to 14 days first post-dosing for FE.
Secondary outcomes (5)
PK Evaluation（Cmax）
Pharmacokinetic characteristics after administration (Cmax）
Measured: up to 72 hours post-dosing for SAD and FE，up to 10 days post-dosing for MAD
PK Evaluation（Tmax）
Pharmacokinetic characteristics after administration
Measured: up to 72 hours post-dosing for SAD and FE，up to 10 days post-dosing for MAD
PK Evaluation（ AUC0-T）
Pharmacokinetic characteristics after administration (AUC0-T）
Measured: up to 72 hours post-dosing for SAD and FE，up to 10 days post-dosing for MAD
PK Evaluation ( AUC0-∞）
Pharmacokinetic characteristics after administration ( AUC0-∞）
Measured: up to 72 hours post-dosing for SAD and FE，up to 10 days post-dosing for MAD
PD evaluation
urinary Rac1 levels
Measured: up to 12 hour post-dosing on Day 1 for SAD and up to 12 hour post-dosing on Day 1 & D7 for MAD
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start8 Dec 2025
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FSGSStudies 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
- Sequential
- Model description
- Part 1and Part 2 are sequential, Part 3 is crossover.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Consun Pharmaceutical Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07267026
- Sponsor's protocol ID
- PR-CR-SK(09)-101
- Status last verified
- Sep 2026
- First submitted
- 17 Nov 2025
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No