Multiple Ascending Dose Study of DW4421
A Phase 1 Clinical Trial to Evaluate the Safety, the Pharmacokinetics and Pharmacodynamics After Multiple Administration of DW4421 in Healthy Adult Volunteers
1 other identifier
interventional
56
1 country
1
Brief Summary
Multiple Ascending Dose of DW4421, phase I
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Sep 2026
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 24, 2026
CompletedFirst Posted
Study publicly available on registry
July 8, 2026
CompletedStudy Start
First participant enrolled
September 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
Study Completion
Last participant's last visit for all outcomes
February 1, 2027
July 8, 2026
July 1, 2026
3 months
June 24, 2026
July 2, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
AUCτ,ss, Area under the drug concentration-time curve of DW4421 following multiple oral administration
Assessment of pharmacokinetic parameters of DW4421 after multiple oral administration
Day 7
Cmax of DW4421 following multiple oral administration
Assessment of pharmacokinetic parameters of DW4421 after multiple oral administration
Day 7
Study Arms (7)
cohort 1 (DW4421S 5mg)
EXPERIMENTALDW4421S-T0, 1 tablet will be orally administered in BID for 7days
cohort 2 (DW4421S 10mg)
EXPERIMENTALDW4421S-T0, 1 tablet will be orally administered in QD for 7days
cohort 3 (DW4421S 15mg)
EXPERIMENTALDW4421S-T2, 1 tablet will be orally administered in QD for 7days
cohort 4 (DW4421S 20mg)
EXPERIMENTALDW4421S-T1, 1 tablet will be orally administered in QD for 7days
cohort 5 (DW4421S 30mg)
EXPERIMENTALDW4421S-T3, 1 tablet will be orally administered in QD for 7days
cohort 6 (DW4421S 40mg)
EXPERIMENTALDW4421S, 1 tablet will be orally administered in QD for 7days
cohort 7 (Zastaprazan 20mg)
ACTIVE COMPARATORDW4421-3, 1 tablet will be orally administered in QD for 7days
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Those who have clinical significant liver, kidney, nervous system, respiratory, endocrine, hematology and oncology, cardiovascular, urinary, and mental diseases or past history.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chungbuk National University Hospital
Cheongju-si, North Chungcheong, South Korea
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 24, 2026
First Posted
July 8, 2026
Study Start (Estimated)
September 1, 2026
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
February 1, 2027
Last Updated
July 8, 2026
Record last verified: 2026-07