Actively Recruiting
SAL0140 Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study in a Healthy Chinese Population
Led by Shenzhen Salubris Pharmaceuticals Co., Ltd. · Updated on 2025-07-04
82
Participants Needed
1
Research Sites
33 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate the safety, tolerability pharmacokinetics and pharmacodynamics of SAL0140 healthy Chinese population.
CONDITIONS
Official Title
SAL0140 Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study in a Healthy Chinese Population
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects have fully understood and voluntarily signed the informed consent form and can comply with its requirements
- Male or female aged 18 to 65 years
- Male body weight at least 50 kg, female body weight at least 45 kg, with BMI between 19.0 and 26.0 kg/m2 at screening
- All examinations including physical exam, vital signs, lab tests, ECG, chest X-ray show no abnormalities or only minor non-clinically significant findings
You will not qualify if you...
- History or presence of orthostatic tachycardia or hypotension, or symptoms like dizziness or fatigue upon standing
- Use of corticosteroids within 3 months prior to dosing
- Personal or family history of long QT syndrome, torsades de pointes, complex arrhythmias, or sudden death
- Prolonged QTcF interval greater than 450 msec on ECG
- Potassium levels above normal or sodium levels below normal in lab tests
- Known allergies to study drug excipients or history of severe allergic reactions
- Any disease or condition affecting safety evaluation or drug processing, including CNS, cardiovascular, digestive, respiratory, urinary, blood, immune, psychiatric, metabolic disorders, or relevant surgeries
- History of gastric surgery, vagotomy, bowel resection, or surgeries affecting gastrointestinal function
- Receipt of live or attenuated vaccines within 4 weeks prior to screening
- Excessive consumption of caffeinated beverages (more than 8 cups daily) or inability to stop during trial
- Use of prescription drugs, over-the-counter meds, Chinese herbs, or supplements within 14 days prior to dosing
- Long-term use or recent consumption of xanthine-rich or grapefruit-containing products within 48 hours prior to dosing
- Smoking within 3 months prior to screening or inability to stop tobacco use during trial
- Participation in other clinical trials with investigational drugs within 3 months prior to screening
- Blood donation or loss of 400 mL or more, blood transfusion within 3 months prior to screening
- Unprotected sexual intercourse within 2 weeks prior to screening or inability to use effective contraception during study
- Pregnancy, lactation, or positive pregnancy screening
- Alcohol use exceeding 14 standard units per week or inability to stop alcohol during trial
- Positive drug abuse screening or history of drug abuse
- Positive tests for hepatitis B, hepatitis C, syphilis, or HIV
- Poor compliance or other factors making participation unsuitable
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, China, 510515
Actively Recruiting
Research Team
C
Chongyuan Xu, Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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