RecruitingPhase 1NCT07267026

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

Sponsor

Consun Pharmaceutical Group

Enrollment

84 participants

Start Date

Dec 8, 2025

Study Type

INTERVENTIONAL

Conditions

FSGS MCD

Summary

This Phase 1 trial consists of three parts: Part 1 is a Single Ascending Dose (SAD) study, Part 2 is a Multiple Ascending Dose (MAD) study. Both parts adopt a randomized, double-blind, placebo-controlled design. Part 3 is a randomized, open-label, single-dose, two-period crossover self-controlled design FE study.

Eligibility

Min Age: 18 YearsMax Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Placebo and a drug called SK-09 for people with fsgs and mcd. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 55 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSK-09

SAD:Dose groups of 20 mg, 50 mg, 100 mg, 200 mg, 400 mg, and 500 mg were given. MAD：Dose groups (low100 mg BID, 200 mg BID, and 500mg QD or 300mg BID/medium/high, based on Part 1 SAD results) will be given. FE：Dose group (150mg) was given.

DRUGPlacebo

SAD：Dose groups of 20 mg, 50 mg, 100 mg, 200 mg, 400 mg, and 500 mg were given. MAD：Dose groups (low100 mg BID, 200 mg BID, and 500mg QD or 300mg BID/medium/high, based on Part 1 SAD results) were given.