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

A Randomized, Open-label, Single-dose, Parallel-design, Phase 1 Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of DW5524 in Healthy Adult Volunteers

Status

Not yet recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07349589

Enrollment

Registered

2026-01-20

Start date

2026-02-01

Completion date

2026-12-01

Last updated

2026-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Adult

Brief summary

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

Interventions

DRUGDW5524-A

DW5524-A

DRUGDW5524

DW5524

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
AUC0-t	up to 8 hour	Pharmacodynamic DW5524
Cmax	up to 8 hour	Pharmacodynamic DW5524

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026