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

Peking University

Status and phase: Completed; Phase 1

Conditions: Thrombosis; Cardiovascular Diseases

Treatments: Drug: Placebo Comparator: Single dose group; Drug: Experimental: Food effect group; Drug: Active Comparator: Multiple dose group

Study type: Interventional

Funder types: Other

Identifiers

NCT07618351

PKUFH-VTE-MASLD-2026

Details and patient eligibility

About

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.

Enrollment: 627 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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627 participants in 3 patient groups, including a placebo group

Single dose group

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo Comparator: Single dose group

Food effect group

Experimental group

Description:

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.

Treatment:

Drug: Experimental: Food effect group

Multiple dose group

Active Comparator group

Description:

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.

Treatment:

Drug: Active Comparator: Multiple dose group