The goal of this clinical trial is to evaluate the safety, tolerability and pharmacokinetic characteristics of JYP0061 in healthy adult subjects. The main questions it aims to answer are: safety and tolerability of JYP0061 in healthy subjects, the pharmacokinetic characteristics after single and multiple doses and the effect of food on the pharmacokinetic characteristics. Participants will be treated with JYP0061 orally and safety and pharmacokinetic evaluations will be conducted according to the protocol.
This study will be an double-blinded, single-center phase I clinical trial. After being informed about the study and potential risks, all subjects giving written informed consent will undergo a 2-week screening period to determine eligibility for study entry. And then subjects will be administered for single-dose treatment or 10-day multiple-dose treatment and 5-day safety follow up after the last dose of treatment. The safety and pharmacokinetic measures will be conducted according to the protocol.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
94
Shanghai Xuhui District Central Hospital
Shanghai, Shanghai Municipality, China
The peak plasma concentration that JYP0061 achieves after dosing.
Evaluate patients' electrocardiogram data to detect whether the treatment causes maximum observed concentration of drug substance in plasma
Time frame: up to 4 weeks
The time to reach the maximum concentration of JYP0061 in the bloodstream after administration.
Time when the maximum concentration is achieved
Time frame: up to 4 weeks
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