Health TrialsbyHealthPanel

Phase 1 Clinical Trial to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DWP212525 in Healthy Volunteers

ConditionAutoimmune Diseases
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age19-55
SponsorDaewoong Pharmaceutical Co. LTD.

About this trial

The safety and tolerability of single and multiple administration of DWP212525

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Healthy adult volunteers aged 19 to 55 years

Those with a body weight ≥ 50.0 kg to ≤ 90.0 kg with a body mass index (BMI) of ≥ 18.0 kg/m2 to ≤ 30.0 kg/m2

Received a sufficient explanation on this study

Eligible as subjects in the study

Disqualifiers

History of diseases such as clinically significant disease of hepatobiliary

Following conditions applicable to clinically significant acute or chronic infections or the past history confirmed via an interview

Hemato-oncologic diseases, including malignant tumor diagnosis

Past history of tuberculosis infection or confirmed tuberculosis in the IGRA test and chest X-ray test

Trial design

Design model

Sequential

Treatments tested in this trial

  • DWP212525 XXmg

    Drug

    DWP212525 XXmg

  • DWP212525 placebo

    Drug

    DWP212525 placebo

Treatment groups

84 Participants
are divided into 11 treatment groups

11

Treatment groups

See each treatment group below.

Group A: Cohort1Experimental treatment 2 interventions
Group B: Cohort2Experimental treatment 2 interventions
Group C: Cohort3Experimental treatment 2 interventions
Group D: Cohort4Experimental treatment 2 interventions
Group E: Cohort5Experimental treatment 2 interventions
Group F: Cohort6Experimental treatment 2 interventions
Group G: Cohort7Experimental treatment 2 interventions
Group H: Cohort8Experimental treatment 2 interventions
Group I: Cohort9Experimental treatment 2 interventions
Group J: Cohort10Experimental treatment 2 interventions
Group K: Cohort 11Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

PK profiles of DWP212525

Area under the plasma drug concentration-time curve from 0 to last

Time frame
Day 1
2

PK profiles of DWP212525

The maximum or peak concentration between zero and dosing interval

Time frame
Day 1
3

PK profiles of DWP212525

Time of maximum concentration

Time frame
Day 1
4

Safety profiles

AE, SAE, etc.

Time frame
Day 1

Secondary outcomes

Other outcomes

Sponsors and contacts

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

Daewoong Pharmaceutical Co. LTD.

Lead sponsor

Source ClinicalTrials.gov
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