이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

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

2026년 5월 26일 업데이트: 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.

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

627

단계

  • 1단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인

건강한 자원 봉사자를 받아들입니다

예

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 네 배로

무기와 개입

참가자 그룹 / 팔
개입 / 치료
위약 비교기: 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.
의약품: 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.
실험적: 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.
의약품: 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.
활성 비교기: 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.
의약품: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
기간: 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
기간: 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
기간: 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
기간: 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.

2차 결과 측정

결과 측정
측정값 설명
기간
Change from Baseline in Coagulation Function: Coagulation Factor XI (FXI) Activity
기간: 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
기간: 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
기간: 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).

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Peking University First Hospital

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2023년 6월 20일

기본 완료 (실제)

2025년 1월 23일

연구 완료 (실제)

2026년 3월 12일

연구 등록 날짜

최초 제출

2026년 5월 17일

QC 기준을 충족하는 최초 제출

2026년 5월 26일

처음 게시됨 (실제)

2026년 6월 1일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 1일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 5월 26일

마지막으로 확인됨

2026년 4월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • PKUFH-VTE-MASLD-2026

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

심혈관 질환에 대한 임상 시험

Placebo Comparator: Single dose group에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Australia

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

구독하다