Evaluate the Safety, Tolerability and Pharmacokinetics of DW5524 in Healthy Adult Volunteers

ConditionHealthy Adult

Trial statusNot yet recruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age19+

SponsorDaewon Pharmaceutical Co., Ltd.

About this trial

This study aimed to evaluate the safety and pharmacokinetic characteristics of DW5524 in healthy adult volunteers.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Healthy adult volunteers aged 19 years or older at the time of screening

Individuals weighing 50.0 kg or more and having a body mass index (BMI) between 18.0 kg/m2 and 30.0 kg/m2 at the time of screening

Disqualifiers

Those with a current or past medical history of clinically significant liver, kidney, nervous, mental, respiratory, endocrine, blood disease, tumor, genitourinary, cardiovascular, digestive, or musculoskeletal diseases.

Trial design

Design model

Parallel

Treatments tested in this trial

DW5524
Drug
DW5524
DW5524-A
Drug
DW5524-A

Treatment groups

48 Participants

are divided into 4 treatment groups

Group A: Group1Experimental treatment 1 intervention

Group B: Group2Experimental treatment 1 intervention

Group C: Group3Experimental treatment 1 intervention

Group D: Group4Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

AUC0-t

Pharmacodynamic DW5524

Time frame

up to 8 hour

Cmax

Pharmacodynamic DW5524

Time frame

up to 8 hour

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Daewon Pharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: