A Study to Evaluate the Safety, Tolerability and PK of 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 Phase 1 trial consists of two parts: Part 1 is a Single Ascending Dose (SAD) study, and Part 2 is a Multiple Ascending Dose (MAD) study. Both parts adopt a randomized, double-blind, placebo-controlled design.

Study Overview

• Status: Recruiting
• Conditions: FSGS; MCD
• Intervention / Treatment: Drug: SK-09; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Estimated): 72
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Hong Zhou, Master; Phone Number: 13671170530; Email: zhouh807737@chinaconsun.com
• Study Contact Backup: Name: Yingying Song, Master; Phone Number: 13936455906; Email: songyy807932@chinaconsun.com

Study Locations

• Australia
  • Queensland
    • Herston, Queensland, Australia
      • Recruiting
      • Q-Pharm Pty Ltd.
      • Contact: Teena Pisarev Chief Executive Officer; Phone Number: 0737072720; Email: g.wong@nucleusnetwork.com.au
      • Principal Investigator: Gloria Yee Man Wong, Doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SK-09; 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 dose groups (low/medium/high, based on Part 1 SAD results) will be sequentially evaluated.	Drug: SK-09; Dose groups of 20 mg, 50 mg, 100 mg, 200 mg, 400 mg, and 500 mg were given.
Placebo Comparator: Placebo; 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 dose groups (low/medium/high, based on Part 1 SAD results) will be sequentially evaluated.	Drug: Placebo; Dose groups of 20 mg, 50 mg, 100 mg, 200 mg, 400 mg, and 500 mg were given.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Evaluation	Number of participants with AE, with abnormal Vital Signs, abnormal Physical Examination findings, abnormal Laboratory Tests results, abnormal 12-lead ECG readings	up to 8 days post-dosing for SAD and up to 20 days post-dosing for MAD

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PK Evaluation（Cmax）	Pharmacokinetic characteristics after administration (Cmax）	up to 72 hours post-dosing for SAD and up to 16 days post-dosing for MAD
PK Evaluation（Tmax）	Pharmacokinetic characteristics after administration	up to 72 hours post-dosing for SAD and up to 16 days post-dosing for MAD
PK Evaluation（ AUC0-T）	Pharmacokinetic characteristics after administration (AUC0-T）	up to 72 hours post-dosing for SAD and up to 16 days post-dosing for MAD
PK Evaluation ( AUC0-∞）	Pharmacokinetic characteristics after administration ( AUC0-∞）	up to 72 hours post-dosing for SAD and up to 16 days post-dosing for MAD
PD evaluation	urinary Rac1 levels	up to 12 hour post-dosing on Day 1 for SAD and pending for MAD

Collaborators and Investigators

• Sponsor: Consun Pharmaceutical Group

Study record dates

Study Major Dates

• Study Start (Actual): December 8, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: November 17, 2025
• First Submitted That Met QC Criteria: November 24, 2025
• First Posted (Actual): December 5, 2025

Study Record Updates

• Last Update Posted (Actual): March 19, 2026
• Last Update Submitted That Met QC Criteria: March 17, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Macular dystrophy, corneal type 1
• Other Study ID Numbers: PR-CR-SK(09)-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No