Actively Recruiting
A Phase 1, Randomized, Double-Blind Placebo-Controlled Single and Multiple Dose Study Plus Food Effect Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of SAL0140 in Healthy Chinese Subjects
Led by Shenzhen Salubris Pharmaceuticals Co., Ltd. · Updated on 2025-07-04
82
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying SAL0140 to assess its safety, tolerability, and how the body processes and responds to the drug in healthy Chinese adults aged 18 to 65 years. This Phase 1 trial includes adults of both genders and aims to understand the effects of SAL0140 through different dosing strategies. The trial also examines how food intake affects the drug's behavior in the body, contributing to a comprehensive evaluation. The study consists of three parts. Part A involves a single ascending dose design where participants receive increasing oral doses of SAL0140 or placebo to assess safety and drug effects. Part B uses a two-period crossover design to evaluate the impact of food on the drug's pharmacokinetics with single doses. Part C is a multiple ascending dose study, with participants receiving repeated doses of SAL0140 or placebo. Each part enrolls separate groups, and participants take either the study drug or placebo according to random assignment. Participants will undergo health assessments including physical exams, vital signs, lab tests, ECGs, and chest X-rays to monitor safety. Researchers will track adverse events and heart activity from dosing through follow-up days. The study carefully monitors participants up to 28 days after dosing to observe any side effects or changes in heart function. Each participant only joins one dosing group in one part of the study, with the total duration depending on the assigned group.
CONDITIONS
Brief 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 (including 18 and 65 years old)
- Male body weight of at least 50 kg, female body weight of at least 45 kg, and body mass index (BMI) between 19.0 and 26.0 kg/m2 at screening
- All examinations including physical exam, vital signs, laboratory tests, ECG, and chest X-ray show no abnormalities or only minor abnormalities deemed non-clinically significant
You will not qualify if you...
- Subjects with orthostatic tachycardia or orthostatic hypotension at screening or history of related symptoms
- 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 above 450 msec on ECG
- Potassium levels above normal or sodium levels below normal in biochemistry tests
- Known allergies to excipients in the study drug or history of severe allergic reactions
- Any disease or condition affecting safety evaluation or drug disposition including central nervous, cardiovascular, digestive, respiratory, urinary, blood, immune, psychiatric, metabolic disorders, or gastrointestinal surgery except appendectomy
- History of gastric surgery, vagotomy, bowel resection, or surgeries affecting gastrointestinal motility, pH, or absorption
- Receipt of live or attenuated vaccines within 4 weeks prior to screening
- Excessive consumption of tea, coffee, or caffeinated beverages over 8 cups daily or within 48 hours before dosing
- Use of prescription drugs, over-the-counter medications, Chinese herbs, or dietary supplements within 14 days prior to dosing
- History of long-term consumption or recent intake of xanthine-rich or grapefruit products within 48 hours before dosing
- Smoking within 3 months prior to screening or inability to stop tobacco use during the trial
- Participation in other clinical trials with investigational drugs within 3 months prior to screening
- Blood donation or loss over 400 mL, blood transfusion, or blood product receipt within 3 months prior to screening
- Unprotected sexual intercourse within 2 weeks prior to screening or pregnancy/plans for pregnancy without effective contraception
- Pregnant or lactating women, or positive pregnancy screening results
- Alcohol use exceeding specified limits within 3 months prior to screening or inability to stop during the trial
- Positive drug abuse screening or history of drug abuse or illicit drug use
- Positive tests for hepatitis B, hepatitis C, syphilis, or HIV
- Poor compliance or other factors making participation unsuitable as judged by the investigator
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 28 days depending on dose group and study part
Participants receive single or multiple oral doses of SAL0140 or placebo depending on the study part and dose cohort. Parts include single ascending dose, food effect study, and multiple ascending dose.
Multiple visits depending on cohort assignment, including dosing and pharmacokinetic sampling visits
Duration - Up to 28 days post-dose depending on study part
Participants are monitored for safety, tolerability, and pharmacodynamic outcomes after dosing.
Follow-up visits as scheduled for safety assessments up to Day 28
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.
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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