NCT07267026

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Consun Pharmaceutical Group · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	SK-09	Dose groups of 20 mg, 50 mg, 100 mg, 200 mg, 400 mg, and 500 mg were given.
DRUG	Placebo	Dose groups of 20 mg, 50 mg, 100 mg, 200 mg, 400 mg, and 500 mg were given.

Timeline

• Start date: 2025-12-08
• Primary completion: 2026-08-31
• Completion: 2026-08-31
• First posted: 2025-12-05
• Last updated: 2026-03-19

Locations

1 site across 1 country: Australia