Actively Recruiting
A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Oral Doses of SK-09 in Healthy Adults
Led by Consun Pharmaceutical Group · Updated on 2026-06-05
72
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a Phase 1 clinical trial to study SK-09, a drug being evaluated in healthy adult volunteers. The study is divided into two parts: Part 1 assesses single ascending doses (SAD) while Part 2 tests multiple ascending doses (MAD). Both parts use a randomized, double-blind, placebo-controlled design to examine safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD). In Part 1, six dose levels of SK-09 tablets (20 mg, 50 mg, 100 mg, 200 mg, 400 mg, and 500 mg) are given as single oral doses. Part 2 includes three dose groups for multiple oral doses based on Part 1 results: low dose (100 mg twice daily), medium dose (200 mg twice daily), and high dose (500 mg once daily or 300 mg twice daily). Placebo groups are included in both parts for comparison. Participants are healthy adults aged 18 to 55 years with body weight of at least 50 kg and BMI between 18.5 and 29.9. They will be monitored for safety up to 8 days after single doses and 14 days after multiple doses. Researchers will evaluate blood levels of the drug (PK) up to 72 hours or 10 days post-dosing and assess drug effects (PD) within 12 hours on dosing days. The trial includes regular lab tests, vital sign checks, and questionnaires to track tolerability and side effects throughout the study period.
CONDITIONS
Brief Title
A Study to Evaluate the Safety, Tolerability and PK of SK-09
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy male and female participants aged 18 to 55 years (inclusive)
- Body weight at least 50 kg
- Body mass index between 18.5 and 29.9 kg/m2 (inclusive)
- Good general health
- Able to understand and voluntarily provide written informed consent
- Use effective contraception with no plans for conception during the trial and for 3 months after the last dose
You will not qualify if you...
- History or current significant cardiovascular, respiratory, gastrointestinal, neurological, or immunologic disorders
- Chronic gastrointestinal conditions needing daily medication or history of bariatric surgery
- Live or attenuated vaccines within 4 weeks before dosing or planned during the study
- Blood pressure outside 90-140 mmHg systolic or 80 mmHg diastolic
- History of major heart problems including myocardial infarction, angina, heart surgery, arrhythmias, or QT prolongation syndrome
- Positive tests for hepatitis B, syphilis, hepatitis C, or HIV
- 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, illicit drug use or dependence within 6 months
- Current smokers unwilling to abstain during study
- Abnormal liver function tests exceeding specified limits
- Blood donation or loss exceeding 400 mL within 3 months
- Use of other investigational products within 30 days or 5 half-lives
- Use of medications, supplements, or herbal products within 2 weeks prior to first dose
- Positive pregnancy test or breastfeeding
- Unprotected sexual activity within 2 weeks prior to first dose
- Any condition posing safety risk or interfering with study participation
- Investigator site staff and their families or sponsor employees involved in the study and their families are excluded
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 8 days post-dosing per dose group
Participants receive single ascending oral doses of SK-09 or placebo to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics.
Multiple visits depending on dose group
Duration - Up to 14 days post-dosing
Participants receive multiple ascending oral doses of SK-09 or placebo to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics.
Multiple visits depending on dosing schedule
Duration - Up to 14 days post-dosing for MAD and up to 8 days for SAD
Participants are monitored for safety and pharmacokinetic outcomes after dosing ends.
Visits as scheduled for safety evaluations
Trial Site Locations
Total: 1 location
1
Q-Pharm Pty Ltd.
Herston, Queensland, Australia
Actively Recruiting
Research Team
Y
Yingying Song, Master
X
Xin Hou, Master
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here