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

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

Plain Language Summary

Simplified for easier understanding

This is an early-phase human trial testing F230 tablets in healthy volunteers. The study is evaluating how the drug behaves in the body — how it is absorbed, processed, and eliminated — and checking for safety. **You may be eligible if...** - You are a healthy adult between 18 and 45 years old - You meet weight requirements (men at least 50 kg, women at least 45 kg) and have a BMI between 19 and 26 - You have passed a comprehensive health exam with no significant findings - You agree not to donate blood, use special medications, or participate in other trials during the study period **You may NOT be eligible if...** - You have any significant health conditions - You are pregnant, breastfeeding, or planning to become pregnant - You use tobacco, alcohol excessively, or recreational drugs - You have participated in another clinical trial recently Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.


Locations(1)

Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology

Hubei, Wuhan, China

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NCT06899815


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