Shanghai Xuhui District Central Hospital
Shanghai, Shanghai Municipality, 200020, China
NCT Number: NCT06137911
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.
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Notify Me18 year–45 year
Male
Interventional
Phase 1
Shanghai, Shanghai Municipality, 200020, China
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
JYP0061 orally administered
Placebo orally administered
Time frame: up to 4 weeks
Evaluate patients' electrocardiogram data to detect whether the treatment causes maximum observed concentration of drug substance in plasma
Time frame: up to 4 weeks
Time when the maximum concentration is achieved
Time frame: up to 4 weeks
Area under the concentration-time curve from time zero to infinity.in healthy subjects.
Guangzhou JOYO Pharma Co., Ltd
Industry
Safety, Tolerability and Pharmacokinetic Characteristics of JYP0061 in Healthy Adult Subjects After Single and Multiple Doses: a Single-center, Randomized, Double-blind, Placebo-controlled, Phase I Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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