Pulmonary HypertensionPhase 1NCT06899815
Preliminary Human Trials of F230 Tablets
A Phase 1 study testing F230 tablets in people with Pulmonary Hypertension, run by Beijing Continent Pharmaceutical Co, Ltd. at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Hypertension
- What is being tested?
- F230 tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteChina
- Study dates
- 15 May 2025to 1 Jul 2026
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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);
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
Hubei, Wuhan, 430022
About this study
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
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.
Read the detailed description
This study consists of three parts: the first part is a single administration study (SAD test), the second part is a multiple administration study (MAD test), and the third part is a Food Effect study, which is divided into multiple cohorts according to dose groups and administration regimens.
Single Administration Trial (SAD) : This randomized, double-blind, placebo-controlled, dose-increasing, single-center clinical study was designed to evaluate the safety, tolerability, and pharmacokinetic profile of F230 single administration in healthy volunteers. A total of 78 healthy adult volunteers were planned to be included.This part is expected to develop 6 dose groups: 3mg, 6mg, 12mg, 20mg, 30mg, 40mg, and the groups are indicated by A1-A6. Group A1 planned to include 8 healthy volunteers (stratified by sex, A1:F230 tablets: placebo =3:1), and group A2-A6 planned to include 14 healthy volunteers (stratified by sex, F230 tablets: placebo =6:1), increasing from the initial dose group to the maximum dose group, with each group receiving only a single dose.Qualified volunteers who met the inclusion criteria and did not meet the exclusion criteria were admitted to the phase I laboratory one day before the experiment (D-1) and randomly grouped. The researchers conducted education on the environment, regulations, etc., unified dinner, fasting after 21:00, and did not refrain from drinking water. On the day of administration, F230 tablets or placebo were taken orally on an empty stomach. From the night before the start of the trial to the end of the trial evaluation period (A1:D-1 ~ D3/A2-A6:D-1 ~ D2), the volunteers were kept in the phase I research room. During the study period, safety assessment and PK biological sample collection were conducted according to the protocol. Volunteers completed a safety check on day 3(A1)/ day 2(A2-A2-A6), and were allowed to leave the study center after a comprehensive assessment by the investigator, and then returned to the study center onday 4(A1)/ day 3(A2-A2-A6) or by telephone for safety follow-up.
Multiple dose trial (MAD) : It is initially planned to conduct three dose groups, with preset doses of 10 mg, 20 mg, and 30 mg, Qd, administered for 7 consecutive days. Each group will include 14 volunteers (stratified by gender, F230 tablets: placebo = 6:1), with a total of 42 volunteers planned. All volunteers will stay at the research center from the day before administration (D-1) until 72 hours after the last dose (D10). During the study period, safety assessments and PK biological sample collection will be conducted according to the protocol. On the 10th day of the study (D10, 72 hours after the last dose), the procedures and related safety checks specified in the protocol will be completed. Volunteers may leave the research center only after a comprehensive evaluation by the investigator. Subsequently, volunteers will return to the research center or have a safety follow-up by phone on the 11th day of the study (D11, 96 hours after the last dose).
Research on the Effect of Food on Drugs:
This part is a randomized, open, two-cycle, double-cross clinical study design, referred to as the food impact study. According to the preliminary results of SAD study, it is expected to carry out a dose group: 20mg, and a total of 16 healthy volunteers are planned to be included. The volunteers are randomly divided into K-C and C-K groups by stratified block randomization method, taking gender as a stratified factor, and are randomly divided into two groups at 1:1 ratio, with 8 cases in each group.
Qualified volunteers who met both the inclusion criteria and did not meet any of the exclusion criteria were admitted to the Phase I research room 1 day before the experiment (D-1) and randomly grouped. The researchers conducted education on the environment, regulations, etc., unified dinner, and fasting after 21:00 without drinking water. In the first cycle, K-C group was given fasting, C-K group was given within half an hour after eating a high-fat meal, and group exit examination was conducted on day 2 (D2). After 3 days (72h) of elution, the volunteers underwent a second cycle of dosing on day 6 (D6). In the second cycle, K-C group was administered within half an hour after eating a high-fat meal, and C-K group was administered on an empty stomach. Safety assessment and PK biological sample collection will be conducted during the study in accordance with protocol requirements.
- Conditions
- Pulmonary Hypertension
- Being tested
- F230 tablets
- Keywords
- Pulmonary hypertension, F230
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
F230 tabletsDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| SAD single dose group | Experimental | A total of 6 dose groups A1-A6: F230 are initially expected to be developed (A1-A6 test groups were administered 3mg, 6mg, 12mg, 20mg, 30mg, 40mg, respectively). The specific incremental dose can be adjusted according to the test situation. The A1 dose group included 8 volunteers (stratified by sex, F230 tablets: placebo =3:1), and the A2 to A6 dose group included 14 volunteers (stratified by sex, F230 tablets: Placebo =6:1), F230 tablets or placebo were taken orally on an empty stomach on the day of administration. From the night before the start of the trial to the end of the trial evaluation period (A1:D-1 ~ D3/A2-A6:D-1 ~ D2), the volunteers were kept in the phase I research room. During the study period, safety assessment and PK biological sample collection were conducted according to the protocol. The volunteers completed a safety check on day 4(A1)or day3(A2-A6). Receives: Drug: F230 tablets |
| MAD multiple dose group | Experimental | It is initially planned to conduct three dose groups, with preset doses of 10 mg, 20 mg, and 30 mg, Qd, administered for 7 consecutive days. Each group will include 14 volunteers (stratified by gender, F230 tablets: placebo = 6:1), with a total of 42 volunteers planned. All volunteers will stay at the research center from the day before administration (D-1) until 72 hours after the last dose (D10). During the study period, safety assessments and PK biological sample collection will be conducted according to the protocol. On the 10th day of the study (D10, 72 hours after the last dose), the procedures and related safety checks specified in the protocol will be completed. Volunteers may leave the research center only after a comprehensive evaluation by the investigator. Subsequently, volunteers will return to the research center or have a safety follow-up by phone on the 11th day of the study (D11, 96 hours after the last dose). Receives: Drug: F230 tablets |
| Research on the effects of food on drugs | Experimental | It is planned to conduct a 20 mg dose group, with an intended enrollment of 16 volunteers. Using gender as a stratification factor, volunteers will be randomly assigned to two dosing sequence groups (K-C group and C-K group). Eight volunteers will receive the drug under fasting conditions in Period 1, while the other eight will consume a high-fat meal first and then receive the drug within 30 minutes in Period 1, with washout on Day 2. After a 3-day (72-hour) washout period, volunteers will proceed to the second dosing period on Day 6. Safety checks will be completed on study Day 7, after which volunteers may leave the research center. A safety follow-up will be conducted on Day 8. Receives: Drug: F230 tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Single dose:PK parameters: Cmax
Blood PK parameters
Measured: Within 48 hours of dosing
Single dose:PK parameters: Tmax
Blood PK parameters
Measured: Within 48 hours of dosing
Single dose:PK parameters: AUC0-t
Blood PK parameters
Measured: Within 48 hours of dosing
Single dose:PK parameters: AUC0-∞
Blood PK parameters
Measured: Within 48 hours of dosing
Single dose:PK parameters: t1/2
Blood PK parameters
Measured: Within 48 hours of dosing
Single dose:PK parameters: λz
Blood PK parameters
Measured: Within 48 hours of dosing
Single dose:PK parameters: Vz/F
Blood PK parameters
Measured: Within 48 hours of dosing
Single dose:PK parameters: CL/F
Blood PK parameters
Measured: Within 48 hours of dosing
Single dose:PK parameters: AUC_%Extrap
Blood PK parameters
Measured: Within 48 hours of dosing
Single dose:PK parameters: MRT
Blood PK parameters
Measured: Within 48 hours of dosing
Single dose:PK parameters: Ae_u (t1-t2)
Urine PK parameters
Measured: Within 48 hours of dosing
Single dose:PK parameters: Ae_u (0-t)
Urine PK parameters
Measured: Within 48 hours of dosing
Single dose:PK parameters: Rate_u (max)
Urine PK parameters
Measured: Within 48 hours of dosing
Single dose:PK parameters:Fe_u (0-t)
Urine PK parameters
Measured: Within 48 hours of dosing
Multiple administration: PK parameters:Cmax,ss
Blood PK parameters
Measured: Within 48 hours of dosing
Multiple administration: PK parameters:Tmax,ss
Blood PK parameters
Measured: Within 48 hours of dosing
Multiple administration: PK parameters: AUC0-τ,ss
Blood PK parameters
Measured: Within 48 hours of dosing
Multiple administration: PK parameters: AUC0-t
Blood PK parameters
Measured: Within 48 hours of dosing
Multiple administration: PK parameters: AUC0-∞
Blood PK parameters
Measured: Within 48 hours of dosing
Multiple administration: PK parameters:Cmin,ss
Blood PK parameters
Measured: Within 48 hours of dosing
Multiple administration: PK parameters: Cav,ss
Blood PK parameters
Measured: Within 48 hours of dosing
Multiple administration: PK parameters: t1/2
Blood PK parameters
Measured: Within 48 hours of dosing
Multiple administration: PK parameters: λz
Blood PK parameters
Measured: Within 48 hours of dosing
Multiple administration: PK parameters: CLss/F
Blood PK parameters
Measured: Within 48 hours of dosing
Multiple administration: PK parameters: AUC_%Extrap
Blood PK parameters
Measured: Within 48 hours of dosing
Multiple administration: PK parameters: MRT
Blood PK parameters
Measured: Within 48 hours of dosing
Multiple administration: PK parameters: DF
Blood PK parameters
Measured: Within 48 hours of dosing
Multiple administration: PK parameters: Rac
Blood PK parameters
Measured: Within 48 hours of dosing
Effects of food on single pharmacokinetic parameters: Cmax
Blood PK parameters
Measured: Within 48 hours of dosing
Effects of food on single pharmacokinetic parameters: Tmax
Blood PK parameters
Measured: Within 48 hours of dosing
Effects of food on single pharmacokinetic parameters: AUC
Blood PK parameters
Measured: Within 48 hours of dosing
Secondary outcomes (15)
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.
Measured: SAD: 3 days
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.
Measured: MAD: 10 days
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.
Measured: Effects of food on drugs test: 7 days
Safety and tolerance assessment:Vital signs measurement：temperature
Measure the axillary temperature, the normal value is 35.9-36.7℃
Measured: SAD: 3 days;
Safety and tolerance assessment:Vital signs measurement：temperature
Measure the axillary temperature, the normal value is 35.9-36.7℃
Measured: MAD: 10 days
Safety and tolerance assessment:Vital signs measurement：temperature
Measure the axillary temperature, the normal value is 35.9-36.7℃
Measured: Effects of food on drugs test: 7 days
Safety and tolerance assessment:Vital signs measurement：breathing
Adult resting breathing rate 12-20 beats per minute
Measured: SAD: 3 days
Safety and tolerance assessment:Vital signs measurement：breathing
Adult resting breathing rate 12-20 beats per minute
Measured: MAD: 10 days
Safety and tolerance assessment:Vital signs measurement:breathing
Adult resting breathing rate 12-20 beats per minute
Measured: Effects of food on drugs test: 7 days
Safety and tolerance assessment:Vital signs measurement:blood pressure
Systolic and diastolic blood pressure were measured
Measured: SAD: 3 days
Safety and tolerance assessment:Vital signs measurement:blood pressure
Systolic and diastolic blood pressure were measured
Measured: MAD: 10 days
Safety and tolerance assessment:Vital signs measurement:blood pressure
Systolic and diastolic blood pressure were measured
Measured: Effects of food on drugs test: 7 days
Safety and tolerance assessment:12-lead ECG test/holter ECG
A 12-lead ECG is a non-invasive test that records the heart's electrical activity through 12 electrodes placed on the body surface. Includes 6 limb leads (Ⅰ, Ⅱ, Ⅲ, aVR, aVL, aVF) and 6 chest leads (V1-V6).A Holter ECG uses a portable device to continuously record heart activity over 24-48 hours, capturing transient abnormalities during daily activities or symptom episodes.It includes PR interval, QRS wave group, QT interval, ST segment,and PP/RR interval.
Measured: SAD: 3 days
Safety and tolerance assessment:12-lead ECG test/holter ECG
A 12-lead ECG is a non-invasive test that records the heart's electrical activity through 12 electrodes placed on the body surface. Includes 6 limb leads (Ⅰ, Ⅱ, Ⅲ, aVR, aVL, aVF) and 6 chest leads (V1-V6).A Holter ECG uses a portable device to continuously record heart activity over 24-48 hours, capturing transient abnormalities during daily activities or symptom episodes.It includes PR interval, QRS wave group, QT interval, ST segment,and PP/RR interval
Measured: MAD: 10 days
Safety and tolerance assessment:12-lead ECG test/holter ECG
A 12-lead ECG is a non-invasive test that records the heart's electrical activity through 12 electrodes placed on the body surface. Includes 6 limb leads (Ⅰ, Ⅱ, Ⅲ, aVR, aVL, aVF) and 6 chest leads (V1-V6).A Holter ECG uses a portable device to continuously record heart activity over 24-48 hours, capturing transient abnormalities during daily activities or symptom episodes.It includes PR interval, QRS wave group, QT interval, ST segment,and PP/RR interval.
Measured: Effects of food on drugs test: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2025
- Study start15 May 2025
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Continent Pharmaceutical Co, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06899815
- Sponsor's protocol ID
- KDN-F230-202401
- Status last verified
- Mar 2025
- First submitted
- 11 Mar 2025
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No