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

Daewoong Pharmaceutical

Status and phase: Unknown; Phase 1

Conditions: Healthy

Treatments: Drug: Normal saline; Drug: DWP14012 Tablet; Drug: DWJ1521

Study type: Interventional

Funder types: Industry

Identifiers

NCT04827472

DW_DWJ1521101

Details and patient eligibility

About

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.

Enrollment: 36 estimated patients

Sex: All

Ages: 19 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy adults aged 19 to 50 years old at the time of screening test
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

1. 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
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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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36 participants in 6 patient groups

Part1(Cohort1) : DWJ1521 Amg

Experimental group

Treatment:

Drug: Normal saline

Drug: DWJ1521

Part1(Cohort2) : DWJ1521 Bmg

Experimental group

Treatment:

Drug: Normal saline

Drug: DWJ1521

Part1(Cohort3) : DWJ1521 Cmg

Experimental group

Treatment:

Drug: Normal saline

Drug: DWJ1521

Part1(Cohort4) : DWJ1521 Dmg

Experimental group

Treatment:

Drug: Normal saline

Drug: DWJ1521

Part2 : DWJ1521 Xmg

Experimental group

Treatment:

Drug: DWJ1521

Part2 : DWP14012 Tablet

Experimental group

Treatment:

Drug: DWP14012 Tablet