Actively Recruiting
A Study to Evaluate the Safety, Tolerability and PK of SK-09
Led by Consun Pharmaceutical Group · Updated on 2026-03-19
72
Participants Needed
1
Research Sites
38 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study to Evaluate the Safety, Tolerability and PK of SK-09
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy males and females aged 18 to 55 years at screening
- Body weight of at least 50 kg
- Body mass index (BMI) between 18.5 and 29.9 kg/m2
- Good general health
- Able to understand and provide written informed consent
- No plans for conception during the trial and for 3 months after last dose; willing to use effective contraception
You will not qualify if you...
- History or current presence of significant cardiovascular, respiratory, gastrointestinal, neurological, hematologic, or immunologic disorders
- Chronic gastrointestinal conditions requiring daily medication or history of bariatric surgery
- Live or attenuated vaccines within 4 weeks prior to dosing or planned during the study
- Systolic blood pressure less than 90 mmHg or 140 mmHg and above, or diastolic blood pressure 80 mmHg or higher
- History of serious heart conditions including myocardial infarction, angina, bypass surgery, angioplasty, stenting, heart failure, arrhythmias, or QT prolongation
- Positive tests for hepatitis B surface antigen, syphilis antibodies, hepatitis C antibodies, or HIV antibodies
- Major surgery or trauma requiring hospitalization within 6 months
- Hypersensitivity to SK-09 or its components
- Poor venous access or needle phobia affecting study procedures
- History of alcohol abuse, binge drinking, or illicit drug use or dependence within 6 months
- Current smokers unwilling to abstain during the study
- Abnormal liver function tests (AST or ALT ≥ 1.5× ULN; total bilirubin ≥ 1.5× ULN except Gilbert's syndrome)
- Blood loss or donation exceeding 400 mL within 3 months prior to dosing
- Use of other investigational products within 30 days or 5 half-lives before dosing
- Use of any medications including over-the-counter drugs, herbal medicines, vitamins, or supplements within 2 weeks or 5 half-lives prior to first dose
- Positive pregnancy test or breastfeeding
- Unprotected sexual activity within 2 weeks prior to first dose
- Any condition posing safety risks or interfering with study completion as judged by investigator
- Investigator site staff involved in the study and their family members, sponsor employees and their family members
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Q-Pharm Pty Ltd.
Herston, Queensland, Australia
Actively Recruiting
Research Team
H
Hong Zhou, Master
CONTACT
Y
Yingying Song, Master
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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