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A Phase I SAD/MAD and Liver Effect Study of Vitalangio in Venous Thromboembolism Patients .
Sponsor: Peking University First Hospital
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
627
Start Date
2023-06-20
Completion Date
2026-03-12
Last Updated
2026-06-01
Healthy Volunteers
Yes
Conditions
Interventions
Placebo Comparator: Single dose group
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.
Experimental: Food effect group
This open-label, randomized, two-sequence, two-perio Vitalangio1. Participants will be randomized to receive a single, fixed oral dose of td crossover arm evaluates how food impacts the absorption and pharmacokinetics of he drug under two alternating conditions: strictly fasted (following an overnight fast) or fed (30 minutes after a standardized high-fat, high-calorie breakfast). Following the Period 1 administration, a 7-day washout period will be implemented to ensure complete drug elimination. In Period 2, participants will cross over to receive the exact same dose under the alternate dietary condition. No placebo is utilized in this arm. During both periods, intensive blood sampling will be conducted to evaluate and compare key pharmacokinetic parameters, specifically the maximum plasma concentration (Cmax) and area under the curve (AUC), between the fasted and fed states.
Active Comparator: Multiple dose group
This arm also employs a randomized, double-blind, placebo-controlled, sequential dose-escalation design, but focuses on the cumulative effects of the drug. Healthy participants within each dose cohort will be randomized to receive repeated oral administrations of either Vitalangio1 tablets or a matching placebo. The intervention involves taking the study drug continuously over a predetermined number of consecutive days at a specific frequency (e.g., once or twice daily, as guided by the pharmacokinetic results from the single-dose arm). Administration will typically occur at the same time each day to maintain steady-state drug levels. Similar to the single-dose arm, dose escalation to the next cohort is strictly contingent upon a comprehensive safety and tolerability review of the current cohort's data. This arm is designed to assess steady-state pharmacokinetics, drug accumulation, and sustained safety profiles over a prolonged dosing period.
Locations (1)
Peking University First Hospital
Beijing, Beijing Municipality, China