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
This trial accepts healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
F230 tablets
DrugSAD： 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.
Treatment groups
136 Participants
are divided into 3 treatment groupsGroup A: SAD single dose groupExperimental treatment 1 intervention
Group B: MAD multiple dose groupExperimental treatment 1 intervention
Group C: Research on the effects of food on drugsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Single dose:PK parameters: Cmax
Blood PK parameters
Time frame
Within 48 hours of dosing2
Single dose:PK parameters: Tmax
Blood PK parameters
Time frame
Within 48 hours of dosing3
Single dose:PK parameters: AUC0-t
Blood PK parameters
Time frame
Within 48 hours of dosing4
Single dose:PK parameters: AUC0-∞
Blood PK parameters
Time frame
Within 48 hours of dosingSecondary outcomes
1
Safety and tolerance assessment:Adverse event
Adverse events (AE) are all adverse medical events that occur after a clinical study volunteer receives an investigational drug. It may present as symptoms, signs, disease, or abnormalities in laboratory tests, but may not have a causal relationship with the investigational drug. An AE can be an aggravation of an existing disease, symptoms, signs, laboratory abnormalities, or a newly diagnosed disease, newly occurring symptoms, signs, laboratory outliers, etc.
Time frame
SAD: 3 days2
Safety and tolerance assessment:Adverse event
Adverse events (AE) are all adverse medical events that occur after a clinical study volunteer receives an investigational drug. It may present as symptoms, signs, disease, or abnormalities in laboratory tests, but may not have a causal relationship with the investigational drug. An AE can be an aggravation of an existing disease, symptoms, signs, laboratory abnormalities, or a newly diagnosed disease, newly occurring symptoms, signs, laboratory outliers, etc.
Time frame
MAD: 10 days3
Safety and tolerance assessment:Adverse event
Adverse events (AE) are all adverse medical events that occur after a clinical study volunteer receives an investigational drug. It may present as symptoms, signs, disease, or abnormalities in laboratory tests, but may not have a causal relationship with the investigational drug. An AE can be an aggravation of an existing disease, symptoms, signs, laboratory abnormalities, or a newly diagnosed disease, newly occurring symptoms, signs, laboratory outliers, etc.
Time frame
Effects of food on drugs test: 7 days4
Safety and tolerance assessment:Vital signs measurement：temperature
Measure the axillary temperature, the normal value is 35.9-36.7℃
Time frame
SAD: 3 days;Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov