Actively Recruiting
A Study to Evaluate the Safety, Tolerability and PK of SK-08
Led by Consun Pharmaceutical Group · Updated on 2025-06-24
48
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The trial is conducted in a single-center, randomized, double-blind, placebo-controlled, dose-increasing design. To evaluate the safety, tolerability, pharmacokinetics(PK) ,and pharmacodynamics (PD) characteristics of SK-08 in healthy participants.
CONDITIONS
Official Title
A Study to Evaluate the Safety, Tolerability and PK of SK-08
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy male and female participants aged 18 to 45 years (inclusive)
- Male participants must weigh at least 50 kg; female participants must weigh at least 45 kg
- Body mass index (BMI) between 19.0 and 26 kg/m²
- Participants must have no plans for conception during the trial and for 3 months after the last dose
- Must voluntarily use effective contraception and have no plans for sperm or egg donation
- Capable of understanding and voluntarily providing written informed consent prior to any study procedures
You will not qualify if you...
- History of allergies or allergic constitution
- History of chronic or severe diseases affecting cardiovascular, liver, kidney, biliary tract, respiratory, blood and lymphatic, endocrine, immune, mental, neuromuscular, or gastrointestinal systems
- Acute diseases developed within 2 weeks before screening
- History or current condition of hypotension, insufficient blood volume, intracranial hypertension, cerebral hemorrhage, or ocular diseases like angle-closure glaucoma
- Clinical significant electrolyte imbalances such as hypokalemia, hyperkalemia, hypomagnesemia, hypermagnesemia, hypocalcemia, or hypercalcemia
- Use of any drugs or health supplements within 2 weeks before screening
- Use of drugs that may interact with the study drug within 30 days before screening, such as CYP450 inhibitors or inducers
- Major surgical operations within 6 months before screening or planned surgery during the study period
- Receipt of live attenuated vaccines within 2 weeks before screening or planned during the trial
- History of alcohol abuse within 1 year before screening
- Smoking more than 5 cigarettes per day within 3 months before screening or inability to stop tobacco use during the trial
- Intolerance to venipuncture or history of fainting from needles or blood
- Other conditions judged by the investigator as unsuitable for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital，Zhejiang University
Hangzhou, Zhejiang, China, 310003
Actively Recruiting
Research Team
J
JIAN LIU, Master
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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