Actively Recruiting
A Single Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of SYH2085
Led by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Updated on 2026-02-17
74
Participants Needed
1
Research Sites
50 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Randomized, double-blind and placebo-controlled study to assess the safety, tolerability and pharmacokinetics of single ascending doses of SYH2085 and its food effect in China healthy adult participants. The study is composed of 2 parts. Part 1 is to assess the safety, tolerability and pharmacokinetics of a single ascending dose of SYH2085 tablet. Part 2 is to assess the food effect on SYH2085 at a selected dose in a cross-over design.
CONDITIONS
Official Title
A Single Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of SYH2085
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 45 years, male or female
- Body mass index (BMI) between 19.0 and 28.0 kg/m^2
- Minimum weight: 50 kg for males and 45 kg for females
- Normal vital signs, physical exam, ECG, laboratory, and X-ray imaging results
- Agreement to use effective contraception to avoid pregnancy during and 3 months after the study
- Ability to understand and voluntarily sign informed consent
You will not qualify if you...
- History of allergy or hypersensitivity to the study drug or its components
- History of serious diseases affecting pancreas, heart, liver, kidney, blood, nervous or digestive systems
- History of gastrointestinal surgery affecting drug absorption (except appendectomy)
- Surgery within 6 months prior to the study
- Respiratory or systemic acute infection within 2 weeks prior to screening
- Blood loss over 400 mL within 3 months prior to the study
- Participation in another drug trial within 3 months before study start or plans to join another trial
- Vaccination within 28 days before screening or planned during the trial
- Use of prescription drugs, herbal medicines, supplements, or contraceptives affecting drug metabolism within 28 days
- Use of substances affecting liver enzymes (e.g., grapefruit, orange juice) within 28 days
- Significant ECG abnormalities or cardiac conditions
- Abnormal vital signs at screening: fever, high or low blood pressure, or high pulse rate
- Smoking more than 5 cigarettes daily in past 3 months or inability to stop tobacco use during trial
- Excessive caffeine or xanthine consumption or unwillingness to abstain during study
- Alcohol abuse or positive alcohol breath test, or inability to abstain during the trial
- Positive tests for hepatitis B, hepatitis C, syphilis, or HIV
- History or positive screen for drug abuse
- Fear or intolerance to blood sampling
- Pregnancy, breastfeeding, or positive pregnancy test
- Inability to follow standardized diet and schedule
- Any other condition making participation unsuitable per investigator judgment
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Huashan Hospital Fudan University
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
C
Clinical Trials Information Group officer
CONTACT
X
Xiaojie Wu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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