A Study to Evaluate the Safety, Tolerability and PK of SK-09

NCT ID: NCT07267026

Last Updated: 2025-12-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-15
• Study Completion Date: 2026-08-31

Brief Summary

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.

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.

Conditions

FSGS; MCD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

SK-09

Intervention Type: DRUG

Dose groups of 20 mg, 50 mg, 100 mg, 200 mg, 400 mg, and 500 mg were given.

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Dose groups of 20 mg, 50 mg, 100 mg, 200 mg, 400 mg, and 500 mg were given.

Interventions

SK-09

Dose groups of 20 mg, 50 mg, 100 mg, 200 mg, 400 mg, and 500 mg were given.

Intervention Type: DRUG

Placebo

Dose groups of 20 mg, 50 mg, 100 mg, 200 mg, 400 mg, and 500 mg were given.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Consun Pharmaceutical Group

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Q-Pharm Pty Ltd.

Herston, Queensland, Australia

Countries

Australia

Central Contacts

Hong Zhou, Master

Role: CONTACT

zhouh807737@chinaconsun.com

13671170530

Yingying Song, Master

Role: CONTACT

songyy807932@chinaconsun.com

13936455906

Facility Contacts

Teena Pisarev Chief Executive Officer

Role: primary

g.wong@nucleusnetwork.com.au

0737072720

Other Identifiers

PR-CR-SK(09)-101

Identifier Type: -

Identifier Source: org_study_id