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.