The goal of this clinical trial is to assess the safety, tolerability, and pharmacokinetic profiles of Y-3 in healthy adult volunteers in the United States. The main questions it aims to answer are: * What the pharmacokinetic profiles of single ascending doses of Y-3 (40 mg and 60 mg) in the US healthy adult volunteers? * If drug Y-3 (40mg and 60 mg) is safe and tolerate in the US healthy adult volunteers. Researchers will compare drug Y-3 (40 mg and 60 mg) to a placebo (a look-alike substance that contains no drug) to see what the pharmacokinetic profiles of single ascending doses of Y-3 (40 mg and 60 mg) in the US healthy adult volunteers and if drug Y-3 (40mg and 60 mg) is safe and tolerate in the US healthy adult volunteers. Participants will: * Take drug Y-3 (40 mg) or Y-3 (60 mg) or a placebo only once. * Answer questions regarding your medical history. * Comply with the study procedures and requests. * Complete all tests and collections of PK Sampling. * Must not have any special dietary requirements and be able to consume the food (low-fat) provided by Tranquil Clinical Research during your 4-night stay. * Must avoid excessive ( \> 8 cups per day) caffeine consumption (i.e. coffee or tea) during your time in the study. * Must not consume any food or beverage rich in grapefruit, papaya, or mango during your time in the study. * Must not take any other medications, including traditional Chinese medicines and herbal medicines, during your time in the study. * Must avoid sexual activity or use non-drug contraceptive measures (i.e. condoms) during your time in the study. * Female participants must not become pregnant while in the study. * Must not receive any vaccinations during your time in the study. * Must not donate blood for purposes outside of study procedures during your time in the study. * Must not drink alcohol during your time in the study. * Must not smoke during your time in the study. * Inform your Study Doctor if you no longer wish to participate in the study.
Age range
18 Years – 45 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Evaluate the Cmax of single ascending doses of Y-3 (40 mg and 60 mg) in the US healthy adult volunteers by venous blood and Phoenix WinNonlin
Timeframe: treatment period (Day1-Day4)
Evaluate the AUC 0-t of single ascending doses of Y-3 (40 mg and 60 mg) in the US healthy adult volunteers by venous blood and Phoenix WinNonlin.
Timeframe: treatment period (Day1-Day4)
Evaluate the AUC 0-∞ of single ascending doses of Y-3 (40 mg and 60 mg) in the US healthy adult volunteers by venous blood and Phoenix WinNonlin.
Timeframe: treatment period (Day1-Day4)
Evaluate the Tmax of single ascending doses of Y-3 (40 mg and 60 mg) in the US healthy adult volunteers by venous blood and Phoenix WinNonlin.
Timeframe: treatment period (Day1-Day4)
Evaluate the t1/2 of single ascending doses of Y-3 (40 mg and 60 mg) in the US healthy adult volunteers by venous blood and Phoenix WinNonlin.
Timeframe: treatment period (Day1-Day4)
Evaluate the λz of single ascending doses of Y-3 (40 mg and 60 mg) in the US healthy adult volunteers by venous blood and Phoenix WinNonlin.
Timeframe: treatment period (Day1-Day4)
Evaluate the AUC_%Extrap of single ascending doses of Y-3 (40 mg and 60 mg) in the US healthy adult volunteers by venous blood and Phoenix WinNonlin.
Timeframe: treatment period (Day1-Day4)
Evaluate the Vz of single ascending doses of Y-3 (40 mg and 60 mg) in the US healthy adult volunteers by venous blood and Phoenix WinNonlin.
Timeframe: treatment period (Day1-Day4)
Evaluate the CL of single ascending doses of Y-3 (40 mg and 60 mg) in the US healthy adult volunteers by venous blood and Phoenix WinNonlin.
Timeframe: treatment period (Day1-Day4)
Evaluate the MRT 0-t of single ascending doses of Y-3 (40 mg and 60 mg) in the US healthy adult volunteers by venous blood and Phoenix WinNonlin.
Timeframe: treatment period (Day1-Day4)
Evaluate the MRT 0-∞ of single ascending doses of Y-3 (40 mg and 60 mg) in the US healthy adult volunteers by venous blood and Phoenix WinNonlin.
Timeframe: treatment period (Day1-Day4)