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Not yet recruiting NCT07691242

Multiple Ascending Dose Study of DW4421

Phase I Interventional Healthy Adult Volunteers

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: DW4421S-T0, DW4421S-T2, DW4421S-T1, DW4421S-T3.
Who it may be relevant to
Registry conditions: Healthy Adult Volunteers. Basic parameters: 19 years — 50 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 Phase 1 Clinical Trial to Evaluate the Safety, the Pharmacokinetics and Pharmacodynamics After Multiple Administration of DW4421 in Healthy Adult Volunteers

Overview

Multiple Ascending Dose of DW4421, phase I

Interventions

  • Drug DW4421S-T0
    DW4421 5mg
  • Drug DW4421S-T2
    DW4421 15mg
  • Drug DW4421S-T1
    DW4421 20mg
  • Drug DW4421S-T3
    DW4421 30mg
  • Drug DW4421S
    DW4421 40mg
  • Drug DW4421-3
    Zastaprazan 20mg

Primary outcome measures

  • AUCτ,ss, Area under the drug concentration-time curve of DW4421 following multiple oral administration [Time frame: Day 7]
  • Cmax of DW4421 following multiple oral administration [Time frame: Day 7]

Eligibility criteria

Inclusion criteria

  • Healthy adult aged 19 to 50 (inclusive) years, at the time of screening.
  • Subjects weighing between 50 kg and 90 kg with BMI between 18 and 27 kg/m2 (inclusive) at screening visit.

Exclusion criteria

  • Those who have clinical significant liver, kidney, nervous system, respiratory, endocrine, hematology and oncology, cardiovascular, urinary, and mental diseases or past history.

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
Basic science

Study locations

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

Identifiers

NCT: NCT07691242 · DW4421-106

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗