Study to Evaluate the Safety/Tolerability, Pharmacokinetics, and Pharmacodynamics After Intravenous DWJ1521 Administration in Healthy Adult Volunteers
NCT ID: NCT04827472
Last Updated: 2021-06-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
36 participants
INTERVENTIONAL
2021-01-20
2021-07-31
Brief Summary
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The safety/tolerability and pharmacokinetic properties of DWJ1521 single intravenous administration and DWP14012 single oral administration in healthy adults are compared.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Part1(Cohort1) : DWJ1521 Amg
Normal saline
100ml
DWJ1521
Single dose
Part1(Cohort2) : DWJ1521 Bmg
Normal saline
100ml
DWJ1521
Single dose
Part1(Cohort3) : DWJ1521 Cmg
Normal saline
100ml
DWJ1521
Single dose
Part1(Cohort4) : DWJ1521 Dmg
Normal saline
100ml
DWJ1521
Single dose
Part2 : DWJ1521 Xmg
DWJ1521
Single dose
Part2 : DWP14012 Tablet
DWP14012 Tablet
Single dose, Tablet
Interventions
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Normal saline
100ml
DWJ1521
Single dose
DWP14012 Tablet
Single dose, Tablet
Eligibility Criteria
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Inclusion Criteria
2. Those who weigh 55.0 kg or more and 90.0 kg or less at the time of the screening test and have a body mass index (BMI) of 18.0 or more and 28.0 or less ☞ BMI(kg/m2) = weight(kg) / {height(m)}2
Exclusion Criteria
2. Those with a history of gastrointestinal diseases (gastrointestinal ulcers, gastritis, gastric cramps, gastroesophageal reflux disease, Crohn's disease, etc.) that may affect the safety and pharmacokinetics evaluation of investigational drugs, and those with a history of gastrointestinal surgery (However, simple appendic surgery and hernia surgery are excluded)
3. Those who were tested positive for Helicobacter pylori
4. serologic test results (hepatitis B test, hepatitis C test, human immunodeficiency virus (HIV) test) positive
5. Those whose blood AST and ALT exceeds 1.5 times the upper limit of the normal range in screening tests including additional tests.
19 Years
50 Years
ALL
Yes
Sponsors
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Daewoong Pharmaceutical Co. LTD.
INDUSTRY
Responsible Party
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Locations
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Seoul National University Hospital
Seoul, , South Korea
Countries
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Facility Contacts
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Other Identifiers
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DW_DWJ1521101
Identifier Type: -
Identifier Source: org_study_id
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