Safety, tolerability, and how the body handles SK-09

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 trial will test single and repeated oral doses of SK-09 for safety and to see how the body processes them in healthy adults aged 18–55.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: Consun Pharmaceutical Group (Industry-sponsored)
• Locations: 1 site (Herston, Queensland)
• Trial ID: NCT07267026 on ClinicalTrials.gov

What this trial studies

This Phase 1, randomized, double-blind, placebo-controlled trial enrolls healthy adult volunteers to characterize the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of SK-09. Part 1 uses a single ascending dose (SAD) design and Part 2 uses a multiple ascending dose (MAD) design to escalate doses across cohorts. Participants receive oral SK-09 or placebo with close monitoring for adverse events, blood drug levels, and PD markers. The trial is conducted at a clinical pharmacology unit in Herston, Queensland.

Who should consider this trial

Good fit: Ideal candidates are healthy men and women aged 18–55 with body weight ≥50 kg and BMI 18.5–29.9 kg/m2 who have no significant medical conditions and agree to use effective contraception.

Not a fit: People with active cardiovascular, respiratory, gastrointestinal, neurological, hematologic or immunologic disorders, chronic GI conditions requiring daily medication, recent live vaccinations, low systolic blood pressure, pregnancy, or those seeking treatment for FSGS or MCD would not be expected to benefit from or be eligible for this healthy-volunteer study.

Why it matters

Potential benefit: If SK-09 is shown to be safe with predictable PK, it could pave the way for later trials testing whether the drug helps people with FSGS or MCD.

How similar studies have performed: Randomized, double-blind SAD/MAD Phase 1 designs are standard and have successfully defined safety and PK for many experimental medicines, while SK-09 appears to be first-in-human with no prior public human data.

Eligibility criteria

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.

Where this trial is running

Herston, Queensland

• Q-Pharm Pty Ltd. — Herston, Queensland, Australia (Recruiting)

Study contacts

• Study coordinator: Hong Zhou, Master

Conditions FSGS; MCD