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

Daewon Pharmaceutical

Status and phase: Not yet enrolling; Phase 1

Conditions: Healthy Adult

Treatments: Drug: DW5524; Drug: DW5524-A

Study type: Interventional

Funder types: Industry

Identifiers

NCT07349589

DW5524-101

Details and patient eligibility

About

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

Enrollment: 48 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 4 patient groups

Group1

Experimental group

Description:

Group1

Treatment:

Drug: DW5524

Group2

Experimental group

Description:

Group2

Treatment:

Drug: DW5524

Group3

Experimental group

Description:

Group3

Treatment:

Drug: DW5524

Group4

Experimental group

Description:

Group4

Treatment:

Drug: DW5524-A