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Preliminary Human Trials of F230 Tablets
Sponsor: Beijing Continent Pharmaceutical Co, Ltd.
Summary
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.
Official title: A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Food Effects of Single and Multiple Administration of F230 Tablets in Healthy Adult Volunteers
Key Details
Gender
All
Age Range
18 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
136
Start Date
2025-05-15
Completion Date
2026-07-01
Last Updated
2026-03-11
Healthy Volunteers
Yes
Conditions
Interventions
F230 tablets
SAD: A1: F230 tablets 3mg;A2: F230 tablets 6mg;A3: F230 tablets 12mg;A4: F230 tablets 20mg;A5: F230 tablets 30mg;A6: F230 tablets 40mg . MAD: B1: F230 tablets 10mg; B2: F230 tablets 20mg; B3: F230 tablets 30mg; Studies on the effects of food on drugs:Group K-C: The first cycle was fasting administration, and the second cycle was postprandial administration;C-K:The first cycle was given after meals, and the second cycle was given on an empty stomach.
Locations (1)
Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
Hubei, Wuhan, China