A Phase I SAD/MAD and Liver Effect Study of Vitalangio in Venous Thromboembolism Patients . (NCT07618351) | Clinical Trial Compass
CompletedPhase 1
A Phase I SAD/MAD and Liver Effect Study of Vitalangio in Venous Thromboembolism Patients .
China627 participantsStarted 2023-06-20
Plain-language summary
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.
Who can participate
Age range
18 Years – 55 Years
Sex
ALL
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 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\>4…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timeframe: 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).
2
Pharmacokinetics (PK): Maximum Observed Plasma Concentration
Timeframe: 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).
3
Number of Participants with Clinically Significant Changes in Clinical Laboratory Parameters
Timeframe: From baseline (Day 0) to Day 14 post-administration.
4
Pharmacokinetics (PK): Area Under the Plasma Concentration-Time Curve
Timeframe: Pre-dose and at multiple time points post-dose up to 72 hours.