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

NCT07267026 | Recruiting Phase 1

• 1 other identifier: PR-CR-SK(09)-101
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

FSGS; MCD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• PK Evaluation（Cmax）

  up to 72 hours post-dosing for SAD and up to 16 days post-dosing for MAD

• PK Evaluation（Tmax）

  up to 72 hours post-dosing for SAD and up to 16 days post-dosing for MAD

• PK Evaluation（ AUC0-T）

  up to 72 hours post-dosing for SAD and up to 16 days post-dosing for MAD

• PK Evaluation ( AUC0-∞）

  up to 72 hours post-dosing for SAD and up to 16 days post-dosing for MAD

• PD evaluation

  up to 12 hour post-dosing on Day 1 for SAD and pending for MAD

Study Arms (2)

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 dose groups (low/medium/high, based on Part 1 SAD results) will be sequentially evaluated.

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 dose groups (low/medium/high, based on Part 1 SAD results) will be sequentially evaluated.

Drug: Placebo

Interventions

SK-09 DRUG

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

SK-09

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 .

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Consun Pharmaceutical Group: lead

Study Sites (1)

Q-Pharm Pty Ltd.

Herston, Queensland, Australia

RECRUITING

MeSH Terms

Conditions

Macular dystrophy, corneal type 1

Central Study Contacts

Hong Zhou, Master

CONTACT

13671170530; zhouh807737@chinaconsun.com

Yingying Song, Master

CONTACT

13936455906; songyy807932@chinaconsun.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: December 5, 2025
• Study Start: December 8, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: March 19, 2026

Record last verified: 2026-03

Locations

AU (1)