Actively Recruiting
A Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Single-dose SK-08 Tablets in Healthy Adults Aged 18-45
Led by Consun Pharmaceutical Group · Updated on 2025-06-24
48
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a single-center, randomized, double-blind, placebo-controlled, dose-escalation study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of a drug called SK-08 in healthy adults aged 18 to 45 years. This phase 1 trial involves evaluating seven increasing dose groups, enrolling a total of 48 healthy participants. The study is sponsored by Consun Pharmaceutical Group and focuses on understanding how SK-08 behaves in the body and how well it is tolerated. The trial includes seven sequential dose groups ranging from 5 mg to 60 mg of SK-08 or placebo. Participants receive a single dose of either SK-08 or placebo depending on their assigned group. The doses are given once, and the participants are randomly assigned to either the SK-08 or placebo group in a double-blind manner to ensure unbiased assessment. During the study, participants undergo multiple evaluations including safety assessments up to Day 12, detailed pharmacokinetic measurements at various time points up to 96 hours after dosing, and pharmacodynamic monitoring of heart rate, blood pressure, cGMP concentration levels, and QT interval analysis. These tests help researchers understand the effects and movement of the drug in the body. The overall participation duration covers these monitoring periods, ensuring careful observation of any potential effects or side effects.
CONDITIONS
Brief 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) must be between 19.0 and 26 kg/m².
- Participants must not plan to conceive during the trial and for 3 months after the last dose and must use effective contraception.
- Able to understand and voluntarily provide written informed consent before 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 within 2 weeks before screening.
- Conditions such as hypotension, insufficient blood volume, intracranial hypertension, cerebral hemorrhage, or ocular diseases that make participation unsuitable.
- Clinically significant electrolyte imbalances such as hypokalemia or hypercalcemia.
- Use of drugs or health supplements within 2 weeks before screening.
- Use of drugs interacting with the study drug (e.g., CYP450 inhibitors or inducers) within 30 days before screening.
- Major surgeries within 6 months before screening or planned surgeries during the study.
- Live attenuated vaccine within 2 weeks before screening or planned during the trial.
- History of alcohol abuse within one year before screening.
- Smoking more than 5 cigarettes per day on average within 3 months before screening or inability to stop tobacco during the trial.
- Inability to tolerate venipuncture or history of fainting from needles or blood.
- Other conditions deemed unsuitable by the researchers.
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 12 days
Participants receive a single dose of SK-08 or placebo in one of seven sequential dose groups. Safety, tolerability, pharmacokinetics, and pharmacodynamics are evaluated.
Multiple visits within 5 days post-dosing for PK and PD assessments
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
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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