NCT07618351CompletedPhase 1
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
Peking University First Hospital1 site in 1 country627 target enrollmentStarted: June 20, 2023Last updated:
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 627
- Locations
- 1
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Investigators
Study Sites (1)
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