Study to Evaluate the Safety/Tolerability, Pharmacokinetics, and Pharmacodynamics After Intravenous DWJ1521 Administration in Healthy Adult Volunteers

Study Overview
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Brief Summary
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The safety/tolerability and pharmacokinetic properties of DWJ1521 are evaluated after single intravenous administration of DWJ1521 in healthy adults. The safety/tolerability and pharmacokinetic properties of DWJ1521 single intravenous administration and DWP14012 single oral administration in healthy adults are compared.

Official Title
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A Randomized, Double Blind, Placebo-controlled, Single Dose, Dose-escalation Study to Evaluate the Safety/Tolerability, Pharmacokinetics, and Pharmacodynamics After Intravenous DWJ1521 Administration in Healthy Adult Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: Normal saline
* Drug: DWJ1521
* Drug: DWP14012 Tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy adults aged 19 to 50 years old at the time of screening test 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: Clinically significant, liver, kidney, nervous system, immune system, respiratory system, endocrine system, etc., or blood or tumor disease, cardiovascular disease, mental disease (mood disorder, obsessive-compulsive disorder, etc.) or have a history of character 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) Those who were tested positive for Helicobacter pylori serologic test results (hepatitis B test, hepatitis C test, human immunodeficiency virus (HIV) test) positive Those whose blood AST and ALT exceeds 1.5 times the upper limit of the normal range in screening tests including additional tests.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part1(Cohort1) : DWJ1521 Amg<br> | Drug: Normal saline<br>* 100ml<br>Drug: DWJ1521<br>* Single dose<br>|
| Experimental: Part1(Cohort2) : DWJ1521 Bmg<br> | Drug: Normal saline<br>* 100ml<br>Drug: DWJ1521<br>* Single dose<br>|
| Experimental: Part1(Cohort3) : DWJ1521 Cmg<br> | Drug: Normal saline<br>* 100ml<br>Drug: DWJ1521<br>* Single dose<br>|
| Experimental: Part1(Cohort4) : DWJ1521 Dmg<br> | Drug: Normal saline<br>* 100ml<br>Drug: DWJ1521<br>* Single dose<br>|
| Experimental: Part2 : DWJ1521 Xmg<br> | Drug: DWJ1521<br>* Single dose<br>|
| Experimental: Part2 : DWP14012 Tablet<br> | Drug: DWP14012 Tablet<br>* Single dose, Tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24h pH monitoring, the ratio of the time remaining above pH 4, 6 (time%) |  | [Time Frame: [Time Frame: 0 - 72 hours after dosing]] |