The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
NCT Number: NCT07098091
This study is a single-center, single- and multiple-dose escalating study with a food-effect component, designed to evaluate the safety, tolerability, and pharmacokinetic (PK) characteristics of YD0293 tablets following a single oral dose in healthy subjects, as well as the effect of food on PK parameters and the potential effect on the QT interval. The study also aims to assess the safety, tolerability, and PK profile of YD0293 tablets following multiple oral doses in healthy subjects.
Interested in participating?
Request Info18 year–45 year
All sexes
Interventional
Phase 1
Suzhou, Jiangsu, China
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
YD0293 tablet for oral administration
YD0293 placebo tablet for oral administration
Time frame: Single ascending dose(SAD): day1 to day15; Multiple ascending dose(MAD): day1 to day39; Food effect(FE): day1 to day21
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: Single ascending dose(SAD): day1 to day5; Multiple ascending dose(MAD): day1 to day32; Food effect(FE): day1 to day11
Time to reach maximum concentration (Tmax)
Time frame: Single ascending dose(SAD): day1 to day5; Multiple ascending dose(MAD): day1 to day32; Food effect(FE): day1 to day11
Maximum concentration (Cmax)
Time frame: Single ascending dose(SAD): day1 to day5; Multiple ascending dose(MAD): day1 to day32; Food effect(FE): day1 to day11
Area under the plasma concentration-time curve from time 0 to last time of quantifiable concentration (AUC0-t)
Time frame: Single ascending dose(SAD): day1 to day5; Multiple ascending dose(MAD): day1 to day32; Food effect(FE): day1 to day11
Elimination half time (T1/2)
Time frame: Single ascending dose(SAD): day1 to day2
Time frame: Multiple ascending dose(MAD): day1 to day32
Change in active neutrophil elastase concentrations in blood after multiple oral doses of YD0293 from baseline
Shanghai Yidian Pharmaceutical Technology Development Co., Ltd.
Industry
A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effect of Single and Multiple Doses of YD0293 Tablets in Healthy Subjects
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.
Published trials that share one or more normalized conditions with this study.
NCT07161518
Healthy Participants
Palo Alto, California, United States
View Trial DetailsNCT07445269
Healthy Participants
Çorum, Turkey (Türkiye)
View Trial DetailsNCT07370168
Healthy, Healthy Participants
Birmingham, United Kingdom
View Trial DetailsNCT07268378
Behavior, Behavioral Symptoms
Lausanne, Canton of Vaud, Switzerland
View Trial Details