Health TrialsbyHealthPanel

Multiple Ascending Dose Study of DW4421

ConditionHealthy Adult Volunteers
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age19-50
SponsorDaewon Pharmaceutical Co., Ltd.

About this trial

Multiple Ascending Dose of DW4421, phase I

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • DW4421S-T0

    Drug

    DW4421 5mg

  • DW4421S-T2

    Drug

    DW4421 15mg

  • DW4421S-T1

    Drug

    DW4421 20mg

  • DW4421S-T3

    Drug

    DW4421 30mg

  • DW4421S

    Drug

    DW4421 40mg

  • DW4421-3

    Drug

    Zastaprazan 20mg

Treatment groups

56 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Group A: cohort 1 (DW4421S 5mg)Experimental treatment 1 intervention
Group B: cohort 2 (DW4421S 10mg)Experimental treatment 1 intervention
Group C: cohort 3 (DW4421S 15mg)Experimental treatment 1 intervention
Group D: cohort 4 (DW4421S 20mg)Experimental treatment 1 intervention
Group E: cohort 5 (DW4421S 30mg)Experimental treatment 1 intervention
Group F: cohort 6 (DW4421S 40mg)Experimental treatment 1 intervention
Group G: cohort 7 (Zastaprazan 20mg)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Day 7
2

Cmax of DW4421 following multiple oral administration

Assessment of pharmacokinetic parameters of DW4421 after multiple oral administration

Time frame
Day 7

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Daewon Pharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: