New blood clot drug tested in healthy volunteers – no cure yet
NCT ID NCT07618351
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study tested a new drug called Vitalangio1 in 627 healthy adults aged 18–55 to see if it is safe and how the body processes it. Participants took either the drug or a placebo, and some took it with or without food to see how that affects absorption. The study does not aim to treat or cure any disease, but to gather important safety and drug behavior information for future research.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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627 people
The number who actually took part.
- Started
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Jun 2023
- Finished
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Mar 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 55 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Peking University First Hospital
Beijing, Beijing Municipality, 100034, China
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Other studies related to the condition(s) this trial covers.
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