MedTrace Logo

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

NCT07267026 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2026-03-19

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Consun Pharmaceutical Group

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-12-08
Primary Completion
2026-08-31
Completion
2026-08-31

Countries

  • Australia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07267026 on ClinicalTrials.gov