A Phase I SAD/MAD and Liver Effect Study of Vitalangio in... | NCT07618351

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Single dose group	Placebo Comparator	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.	Drug: Placebo Comparator: Single dose group
Food effect group	Experimental	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.	Drug: Experimental: Food effect group
Multiple dose group	Active Comparator	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.	Drug: Active Comparator: Multiple dose group

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Placebo Comparator: Single dose group	Drug	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)	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	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	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	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.

Secondary Outcomes

Measure	Description	Time Frame
Change from Baseline in Coagulation Function: Coagulation Factor XI (FXI) Activity	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).

Eligibility Module

Eligibility Criteria

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

ID	Term
D013927	Thrombosis
D002318	Cardiovascular Diseases

ID	Term
D016769	Embolism and Thrombosis
D014652	Vascular Diseases

ID	Term
D003710	Demography
D011154	Population Characteristics