A Study to Evaluate the Safety, Tolerability, PK and PD of AP303 in Healthy Chinese Participants - Trial NCT06308523
Access comprehensive clinical trial information for NCT06308523 through Pure Global AI's free database. This Phase 1 trial is sponsored by Alebund Pharmaceuticals and is currently Not yet recruiting. The study focuses on Healthy Subjects. Target enrollment is 18 participants.
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Study Focus
Sponsor & Location
Alebund Pharmaceuticals
Timeline & Enrollment
Phase 1
Mar 30, 2024
Jun 30, 2024
Primary Outcome
Cmax,Tmax,AUC0-24h,AUC0-last,AUC0-inf,AUC0-t,t1/2,CL/F,V/F,Cav,Ctrough,Rac,Incidence and severity of adverse events,Incidence of laboratory abnormalities, based on hematology, clinical chemistry, coagulation and urinalysis test results,Effect of AP303 on ECG parameters,Effect of AP303 on ECG parameters,Effect of AP303 on ECG parameters,Effect of AP303 on ECG parameters,Effect of AP303 on ECG parameters,Effect of AP303 on ECG parameters,Vital signs,Effect of AP303 on physical examination result,body weight
Summary
The study will be a single center, double-blind, randomized, placebo-controlled,
 multiple-ascending-dose study to evaluate the safety, tolerability, PK and PD of AP303
 following 2-week oral administration to healthy Chinese participants.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06308523
Non-Device Trial