NCT06308523

A Study to Evaluate the Safety, Tolerability, PK and PD of AP303 in Healthy Chinese Participants

Name: Clinical Trial NCT06308523
Creator: Alebund Pharmaceuticals
Keywords: Healthy Subjects, AP303 150 μg, Phase 1, drug, clinical trial

A Randomized, Double-blind, Placebo-controlled Multiple-ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AP303 Following 2-week Oral Administration in Healthy Chinese Participants.

Alebund Pharmaceuticals·Phase 1·ClinicalTrials.gov·drugNot yet recruiting

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Study focus

Disease/Condition: Healthy Subjects
Drug/Device/Intervention: AP303 150 μg
Study type: Interventional
Intervention type: drug

Sponsor & location

Primary sponsor: Alebund Pharmaceuticals

Timeline & enrollment

Phase: Phase 1
Start date: Mar 30, 2024
End date: Jun 30, 2024
Enrollment: 18 participants

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

Occupational health examinationSeeking and accepting physical, nutritional and chemical interventions known to be hazardous and harmfulRoutine child health examinationExamination and observation for other reasons

Data source

Registry: ClinicalTrials.gov
Trial ID: NCT06308523
Type: Non-Device Trial

About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.