A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study of Single and Multiple Asceding Doses of GV-100 With Food-Effect and Drug Drug Interaction Evaluations in Healthy Participants
This is a first-in-human, multi-part clinical study designed to evaluate the safety, tolerability, pharmacokinetics (PK), food effect, and drug-drug interaction (DDI) potential of GV-100 following oral administration in healthy participants. The study is divided into four parts: Single Ascending Dose (SAD), Multiple Ascending Dose (MAD), Food Effect (FE), and Drug-Drug Interaction (DDI).
• Male or female participants, aged more than or equal 18 to less than or equal to 65 years at the time of providing informed consent, who are non-smokers (no use of tobacco or nicotine-containing products within 3 months prior to screening), with a body mass index (BMI) greater than 18.0 and less than 32.0 kilogram/meter square, and a minimum body weight of 50.0 kilogram.
• Healthy individuals, as determined by the Principal Investigator or delegate, defined as:
‣ No clinically significant illness or surgical procedures within 4 weeks prior to study drug administration.
⁃ No clinically significant history of neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, gastrointestinal, renal, hepatic, or metabolic disorders.
• Capable of understanding the study procedures and willing to provide written informed consent prior to participation.