RecruitingPhase 1NCT06899815

Preliminary Human Trials of F230 Tablets

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

Sponsor

Beijing Continent Pharmaceutical Co, Ltd.

Enrollment

136 participants

Start Date

May 15, 2025

Study Type

INTERVENTIONAL

Conditions

Pulmonary Hypertension

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.

Eligibility

Min Age: 18 YearsMax Age: 45 Years

Inclusion Criteria6

Volunteers must meet all of the following criteria to be selected:
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;
Before participating in the study, have a detailed understanding of the nature, significance, possible benefits, possible inconveniences and potential dangers of the trial, and voluntarily participate in this clinical trial, can communicate well with the investigators, comply with the requirements of the entire study, and have the ability to understand and sign the written informed consent.

Exclusion Criteria7

Volunteers who meet one of the following conditions are not eligible for this study:
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.
(Consultation) Allergy: If there is a history of drug, food allergy or skin allergy;
(Interview) Any drug that inhibits or induces liver metabolism of the drug in the 28 days prior to the use of the study drug (common liver enzyme inducers: barbiturates such as phenobarbital, carbamazepine, aminomide, grofulvin, methylaminopropyl, phenytoin, Grumette, rifampin, dexamethasone; Common liver enzyme inhibitors: chlorpromazine, cimetidine, ciprofloxacin, metronidazole, chloramphenicol, isoniazid, sulfonamide);

Interventions

DRUGF230 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.