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Preliminary Human Trials of F230 Tablets

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated March 11, 2026 (before its estimated July 1, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Secondary endpoints: details revised at 10 of 15 entries
    • Study description shortened, about 129 words
    • Eligibility criteria expanded, about 3 words
    v4
  2. Trial status: Not Yet Recruiting to Recruitingv3 Show 4 more changesShow less
    • Enrollment target: 116 to 136
    • Primary completion date: Apr 30, 2026 to Jul 1, 2026
    • Study description shortened, about 7 words
    • Site details revised
  3. Study title shortened, about 2 wordsv2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06899815
Lead Sponsor Beijing Continent Pharmaceutical Co, Ltd.
Conditions
(from sponsor)		 Pulmonary Hypertension
Related terms Hypertension, Pulmonary
Enrollment 136 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov