Preliminary Human Trials of F230 Tablets
ConditionPulmonary Hypertension
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-45
SponsorBeijing Continent Pharmaceutical Co, Ltd.
About this trial
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.
Eligibility criteria
Qualifiers
Healthy volunteers, half male and half female, should be replaced by volunteers of the same sex;
Age: 18 ~ 45 years old;
Weight: male ≥50kg, female ≥45kg, 19≤BMI≤26 (BMI= weight (kg)/height 2 (m2));
Pass the comprehensive health examination: vital signs, physical examination, blood urine routine, blood pregnancy, blood glucose, blood lipid, blood electrolyte, hepatitis B surface antigen, liver and kidney function, hepatitis C, HIV and syphilis antibody test, 12-lead electrocardiogram, nicotine, urine drug screening, alcohol breath test, abdominal B-ultrasound, chest X-ray examination, etc., no abnormalities or abnormalities have no clinical significance;
Disqualifiers
Participants in any other clinical trial within three months prior to the trial;
Serum ALT > upper limit of normal (ULN), AST > Upper limit of normal (ULN), TBil > upper limit of normal (ULN);
(Inquiry) Are there any underlying liver diseases, such as chronic hepatitis B, chronic hepatitis C, alcoholic liver disease, moderate to severe non-alcoholic fatty liver disease, liver cirrhosis, etc.;
(Consultation) Have any disease that may affect the safety of the trial or the process of the drug in vivo, including but not limited to: Heart, liver, kidney, endocrine, digestive, immune, respiratory, nervous or psychiatric systems, or other pre-existing or existing diseases of the above systems [especially cardiovascular disease including those at risk for cardiovascular disease, any gastrointestinal disease that interferes with drug absorption (e.g. symptoms of irritable bowel syndrome, history of inflammatory bowel disease), active pathological bleeding (e.g. peptic ulcer), urticaria, epilepsy, epilepsy, etc. Sensitive rhinitis, eczematous dermatitis, asthma, active pulmonary tuberculosis, etc.
Trial design
Treatments tested in this trial
- F230 tablets
Treatment groups
136 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov