Actively Recruiting
Preliminary Human Trials of F230 Tablets
Led by Beijing Continent Pharmaceutical Co, Ltd. · Updated on 2026-03-11
136
Participants Needed
1
Research Sites
58 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
F230 is a new Class 1 chemical drug jointly developed by Beijing Contini Pharmaceutical Co., Ltd. for the treatment of pulmonary hypertension (Notification number: 2024LP01242, 2024LP01243). The in vitro activity and in vivo toxicology tests of F230, the lead compound for the treatment of PAH developed by Beijing Contini Pharmaceutical Co., LTD., showed that F230 had the same in vitro activity as the endothelin antagonist on the market. The pharmacodynamics of F230 in rats with nephrogenic hypertension induced by Sunitinib showed that F230 could reduce proteinuria and improve renal index.It is expected to bring higher treatment and survival benefits to the corresponding patients. According to the spirit of NMPA new drug approval, on the basis of the completion of preclinical studies of this drug, the safety, tolerability and pharmacokinetic characteristics of single administration and multiple administration of this drug in healthy volunteers should be investigated first, and the influence of food on the pharmacokinetic characteristics of F230 in humans should be investigated, so as to recommend a safe and effective administration regimen for phase II clinical trials.
CONDITIONS
Official Title
Preliminary Human Trials of F230 Tablets
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy volunteers, half male and half female
- Age between 18 and 45 years
- Weight: males at least 50kg, females at least 45kg
- Body mass index (BMI) between 19 and 26
- Pass comprehensive health exams including vital signs, blood tests, urine tests, ECG, chest X-ray, and others
- Understand the study and voluntarily agree to participate with informed consent
You will not qualify if you...
- Participation in any other clinical trial within 3 months prior to this study
- Elevated liver enzymes (ALT, AST) or total bilirubin above normal limits
- Known underlying liver diseases such as chronic hepatitis B or C, alcoholic liver disease, severe fatty liver, or cirrhosis
- Any disease affecting safety or drug metabolism including heart, kidney, endocrine, digestive, immune, respiratory, nervous, or psychiatric disorders
- History of drug, food, or skin allergies
- Use of drugs affecting liver metabolism within 28 days prior to study drug administration, including common liver enzyme inducers or inhibitors
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
Hubei, Wuhan, China, 430022
Actively Recruiting
Research Team
S
shaojun Shi, Dr
CONTACT
R
Rui Zhang, Dr
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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