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Not yet recruiting NCT07349589

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

Phase I Interventional Healthy Adult

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: DW5524, DW5524-A.
Who it may be relevant to
Registry conditions: Healthy Adult. Basic parameters: from 19 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

  • Drug DW5524
    DW5524
  • Drug DW5524-A
    DW5524-A

Primary outcome measures

  • AUC0-t [Time frame: up to 8 hour]
  • Cmax [Time frame: up to 8 hour]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

South Korea · 1 center
  • Chungbuk National University Hospital — Cheongju-si

Identifiers

NCT: NCT07349589 · DW5524-101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗