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A Study to Evaluate the Safety, Tolerability and PK of SK-09 | Clinical Trials | Clareo Health

RECRUITINGPHASE1

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

NCT07267026•Consun Pharmaceutical Group

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

Yes

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 more criteria

Locations (1)

Q-Pharm Pty Ltd.

Herston, Queensland, Australia

Key Dates

Start Date

December 8, 2025

Primary Completion Date

August 31, 2026

Completion Date

August 31, 2026

Last Updated

March 19, 2026

Enrollment

ESTIMATED participants

Conditions

FSGSMCD

Interventions

SK-09

DRUG

Placebo

DRUG

Contacts

Hong Zhou, Master

CONTACT

13671170530 zhouh807737@chinaconsun.com

Yingying Song, Master

CONTACT

13936455906 songyy807932@chinaconsun.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 19, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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