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A Phase I SAD/MAD and Liver Effect Study of Vitalangio in Venous Thromboembolism Patients .

26. května 2026 aktualizováno: Peking University First Hospital

A Phase I, Randomized, Double-blind, Placebo-controlled, Single, and Multiple-dose Escalation Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Vitalangio1 in Venous Thromboembolism Patients and a Randomized, Open-label, 2-period Crossover Liver Effect Study

The goal of this clinical trial is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of a new drug, Vitalangio1, in healthy male and female volunteers aged 18 to 55 years old.

The main questions it aims to answer are:

What is the safety and tolerability profile of Vitalangio1 following single and multiple-dose administrations? What are the pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of Vitalangio1, and how does food intake affect its absorption and drug metabolism? Researchers will compare participants receiving Vitalangio1 tablets with those receiving a placebo to see if the drug is safe, well-tolerated, and demonstrates the expected pharmacological effects compared to no active treatment.

Participants will:

Receive either Vitalangio1 tablets or a placebo orally (through single or multiple escalating doses).

Participate in a 2-period crossover food effect study, taking the study drug under different dietary conditions (fasted vs. fed).

Undergo continuous medical monitoring, including physical examinations, vital sign measurements, ECGs, and provide blood/urine samples to track the drug's metabolic and safety profile.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Aktuální)

627

Fáze

  • Fáze 1

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Čína
    • Beijing Municipality
      • Beijing, Beijing Municipality, Čína, 100034
        • Peking University First Hospital

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý

Přijímá zdravé dobrovolníky

Ano

Popis

Inclusion Criteria:

  • Healthy subjects aged 18-55 years (including boundary values)
  • Body mass index (BMI) 19-26 kg/m2 (including boundary value), male body weight >= 50.0 kg and <90.0 kg, female body weight >= 45.0 kg and <90.0 kg
  • In good health with no clinically significant abnormalities as determined by physical examination, clinical laboratory tests ,12-lead ECG ,abdominal B-ultrasound and chest X-ray examination
  • Subjects with Fertility (including partners) are willing to voluntarily take effective measures for reasonable contraception within 6 months from the beginning of screening to the last administration of trial drugs; Postmenopausal women should have a menopausal period of >= 1 year ; Within 6 months after receiving the investigational drug, male subjects agreed to use acceptable contraceptive measures and promised not to donate sperm; Female participants agree to use acceptable contraceptive measures and ensure that they do not donate eggs within 6 months from the start of screening until receiving the investigational medication
  • Understand the research procedures and methods, willing and able to give written informed consent and comply with the study procedures and restrictions

Exclusion Criteria:

  • Vital sign examination: body temperature>37.3 ℃, pulse>100 beats/minute, systolic blood pressure >= 140 mmHg or<90 mmHg, diastolic blood pressure >= 90 mmHg or<50 mmHg; The screening period electrocardiogram examination results showed that QTcF>450 ms (male) or 470 ms (female) or conduction block, which was determined by the researcher to be clinically significant
  • Those who have one or more positive testing at screening for hepatitis B virus surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody, treponema pallidum specific antibody
  • Those who have a history of drug abuse ; have a positive urine drug screen result for drugs of abuse at the screening visit
  • Alanine transaminase, AST, creatinine>ULN; Alkaline phosphatase, bilirubin (total bilirubin or direct bilirubin)>1.5 × ULN
  • Those who are suspected of being allergic to the study drug or any ingredient in the study drug
  • Those who have a history of related diseases that lead to abnormal coagulation function in the past
  • Those who have a history of recurrent or chronic infection within one month prior to screening
  • Those who have undergone surgeries within the first 6 months of screening that have been determined by researchers to affect drug absorption, distribution, metabolism, and excretion
  • Those who consume foods within the first 2 weeks of screening that may affect the metabolism of drugs in the body, or those who are considered by researchers to have other diets that affect drug absorption, distribution, metabolism, and excretion
  • Those who have taken any prescription drugs, Over-the-counter drug, health products and Chinese herbal medicines within 2 weeks before screening, or who have taken within 5 half lives of drugs during screening; Plan to take other investigational drugs not included in this study during the trial period
  • Within one month before screening,any dosage form of vaccine needs to be used
  • Those who donate blood or have a total blood loss of >= 200 mL from 1 month prior to screening to administration, or who donate blood or have a total blood loss of >= 400 mL from 3 months prior to screening to administration, or who have received blood transfusions from 8 weeks prior to screening to administration
  • The investigators believe that the subjects are not suitable for other situations in this experime

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Čtyřnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Komparátor placeba: Single dose group
Participants will receive either Vitalangio1 oral tablets or a matching placebo. The intervention consists of a single oral administration at escalating dose levels, which are determined by the safety and tolerability dose-escalation protocol, meaning the actual treatment duration for this specific intervention is only one day.
Lék: Placebo Comparator: Single dose group
In this randomized, double-blind, placebo-controlled arm, eligible healthy participants will be assigned to different consecutive dose-escalation cohorts. Within each cohort, participants will be randomized to receive either a single oral dose of Vitalangio1 tablets or visually identical placebo tablets. The administration will take place under strict fasting conditions (typically following an overnight fast of at least 10 hours) with a standard volume of water. The study follows a sequential dose-escalation design: the first cohort will receive the lowest predefined starting dose. Subsequent cohorts will only receive the next higher dose level after an independent Safety Review Committee (SRC) thoroughly evaluates the safety, tolerability, and preliminary pharmacokinetic (PK) data from the preceding cohort and confirms it is safe to proceed. The primary focus is to monitor for any acute adverse events and determine the maximum tolerated single dose.
Experimentální: Food effect group
Participants follows a two-period crossover design where participants will exclusively receive a selected fixed single dose of the Vitalangio1 oral tablet. The intervention requires each participant to take the single oral dose under two distinct dietary conditions-once in a completely fasted state and once following a high-fat meal. These two administration periods are separated by a specific washout duration, typically seven days, to accurately assess the impact of food on drug absorption.
Lék: Experimental: Food effect group

This open-label, randomized, two-sequence, two-perio Vitalangio1. Participants will be randomized to receive a single, fixed oral dose of td crossover arm evaluates how food impacts the absorption and pharmacokinetics of he drug under two alternating conditions: strictly fasted (following an overnight fast) or fed (30 minutes after a standardized high-fat, high-calorie breakfast).

Following the Period 1 administration, a 7-day washout period will be implemented to ensure complete drug elimination. In Period 2, participants will cross over to receive the exact same dose under the alternate dietary condition. No placebo is utilized in this arm. During both periods, intensive blood sampling will be conducted to evaluate and compare key pharmacokinetic parameters, specifically the maximum plasma concentration (Cmax) and area under the curve (AUC), between the fasted and fed states.
Aktivní komparátor: Multiple dose group
The intervention involves the administration of Vitalangio1 oral tablets or a placebo over a continuous timeframe. Participants will receive multiple escalating doses on consecutive days, with the precise dosage, daily frequency, and overall duration dictated by the multiple-dose testing protocol to evaluate cumulative safety and pharmacokinetics.
Lék: Active Comparator: Multiple dose group
This arm also employs a randomized, double-blind, placebo-controlled, sequential dose-escalation design, but focuses on the cumulative effects of the drug. Healthy participants within each dose cohort will be randomized to receive repeated oral administrations of either Vitalangio1 tablets or a matching placebo. The intervention involves taking the study drug continuously over a predetermined number of consecutive days at a specific frequency (e.g., once or twice daily, as guided by the pharmacokinetic results from the single-dose arm). Administration will typically occur at the same time each day to maintain steady-state drug levels. Similar to the single-dose arm, dose escalation to the next cohort is strictly contingent upon a comprehensive safety and tolerability review of the current cohort's data. This arm is designed to assess steady-state pharmacokinetics, drug accumulation, and sustained safety profiles over a prolonged dosing period.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Časové okno: From the time of the first dose of the study drug until the end of the final safety follow-up visit (typically up to 7 to 14 days following the last dose administration).
Safety and tolerability will be evaluated by monitoring the incidence, severity, and causality of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs). The assessment also includes monitoring clinically significant changes from baseline in vital signs (such as blood pressure, heart rate, and temperature), 12-lead electrocardiograms (ECGs), physical examinations, and clinical laboratory parameters (hematology, serum chemistry, and urinalysis) across the single-dose, multiple-dose, and food effect groups.
From the time of the first dose of the study drug until the end of the final safety follow-up visit (typically up to 7 to 14 days following the last dose administration).
Pharmacokinetics (PK): Maximum Observed Plasma Concentration
Časové okno: Pre-dose and at multiple time points post-dose up to 72 hours (e.g., 0.5, 1, 2, 4, 6, 8, 12, 24, 48, and 72 hours).
The maximum observed plasma concentration of the active components (e.g., serine protease/nattokinase and relevant metabolites) will be determined from the plasma concentration-time profile.
Pre-dose and at multiple time points post-dose up to 72 hours (e.g., 0.5, 1, 2, 4, 6, 8, 12, 24, 48, and 72 hours).
Number of Participants with Clinically Significant Changes in Clinical Laboratory Parameters
Časové okno: From baseline (Day 0) to Day 14 post-administration.
Safety assessment includes monitoring the number of participants with clinically significant abnormalities compared to baseline in hematology, serum chemistry, and urinalysis (including liver and kidney function tests).
From baseline (Day 0) to Day 14 post-administration.
Pharmacokinetics (PK): Area Under the Plasma Concentration-Time Curve
Časové okno: Pre-dose and at multiple time points post-dose up to 72 hours.
The area under the plasma concentration-time curve from time zero to the last measurable concentration will be calculated to assess the total systemic exposure of the intervention.
Pre-dose and at multiple time points post-dose up to 72 hours.

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change from Baseline in Coagulation Function: Coagulation Factor XI (FXI) Activity
Časové okno: Pre-dose (baseline) and at prespecified time points (e.g., 2, 4, 8, 24, and 48 hours post-dose).
Pharmacodynamic efficacy will be assessed by measuring the percentage change in plasma Coagulation Factor XI (FXI) activity levels from baseline, evaluating the intervention's impact on the intrinsic coagulation pathway.
Pre-dose (baseline) and at prespecified time points (e.g., 2, 4, 8, 24, and 48 hours post-dose).
Change from Baseline in Standard Coagulation Parameters
Časové okno: Pre-dose (baseline) and at prespecified time points (e.g., 2, 4, 8, 24, and 48 hours post-dose).
The effect of the intervention on overall coagulation status will be evaluated by measuring the absolute change in activated partial thromboplastin time (aPTT) and prothrombin time (PT) in seconds.
Pre-dose (baseline) and at prespecified time points (e.g., 2, 4, 8, 24, and 48 hours post-dose).
Change from Baseline in Platelet Reactivity
Časové okno: Pre-dose (baseline) and at prespecified time points (e.g., 2, 4, 24, and 48 hours post-dose).
Platelet function and hyperreactivity will be evaluated by measuring the change from baseline in platelet aggregation, specifically monitoring pathways potentially modulated by the intervention (e.g., high-throughput assessment of receptor-mediated platelet activation, including PEAR1-related pathways). Results will be reported as the percentage of maximal platelet aggregation.
Pre-dose (baseline) and at prespecified time points (e.g., 2, 4, 24, and 48 hours post-dose).

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Peking University First Hospital

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

20. června 2023

Primární dokončení (Aktuální)

23. ledna 2025

Dokončení studie (Aktuální)

12. března 2026

Termíny zápisu do studia

První předloženo

17. května 2026

První předloženo, které splnilo kritéria kontroly kvality

26. května 2026

První zveřejněno (Aktuální)

1. června 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

1. června 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

26. května 2026

Naposledy ověřeno

1. dubna 2026

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • PKUFH-VTE-MASLD-2026

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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