RecruitingPhase 1

Preliminary Human Trials of F230 Tablets

China136 participantsStarted 2025-05-15

Plain-language 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.

Who can participate

Age range18 Years – 45 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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 criteria

✕. Participants in any other clinical trial within three months prior to the trial;

What they're measuring

Single dose:PK parameters: Cmax

Timeframe: Within 48 hours of dosing

Single dose:PK parameters: Tmax

Timeframe: Within 48 hours of dosing

Single dose:PK parameters: AUC0-t

Timeframe: Within 48 hours of dosing

Single dose:PK parameters: AUC0-∞

Timeframe: Within 48 hours of dosing

Single dose:PK parameters: t1/2

Timeframe: Within 48 hours of dosing

Single dose:PK parameters: λz

Timeframe: Within 48 hours of dosing

Single dose:PK parameters: Vz/F

Timeframe: Within 48 hours of dosing

Single dose:PK parameters: CL/F

Timeframe: Within 48 hours of dosing

Trial details

NCT IDNCT06899815

SponsorBeijing Continent Pharmaceutical Co, Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-07-01

Contact for this trial

shaojun Shi, Dr

027-85726085 sjshicn@163.com

View on ClinicalTrials.gov More Pulmonary Hypertension trials

Plain-language summary

Who can participate

Age range18 Years – 45 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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 criteria

✕. Participants in any other clinical trial within three months prior to the trial;

What they're measuring

Single dose:PK parameters: Cmax

Timeframe: Within 48 hours of dosing

Single dose:PK parameters: Tmax

Timeframe: Within 48 hours of dosing

Single dose:PK parameters: AUC0-t

Timeframe: Within 48 hours of dosing

Single dose:PK parameters: AUC0-∞

Timeframe: Within 48 hours of dosing

Single dose:PK parameters: t1/2

Timeframe: Within 48 hours of dosing

Single dose:PK parameters: λz

Timeframe: Within 48 hours of dosing

Single dose:PK parameters: Vz/F

Timeframe: Within 48 hours of dosing

Single dose:PK parameters: CL/F

Timeframe: Within 48 hours of dosing