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

Phase 1

• Conditions: Healthy
• Interventions: Drug: Normal saline; Drug: DWP14012 Tablet; Drug: DWJ1521

• Registration Number: NCT04827472
• Lead Sponsor: Daewoong Pharmaceutical Co. LTD.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-20
• Status Verified: 2021-03
• Study First Submitted: 2021-03-25
• Study First Submitted QC: 2021-03-30
• Study First Posted: 2021-04-01
• Last Update Submitted: 2021-06-08
• Last Update Posted: 2021-06-10
• Primary Completion: 2021-06-30
• Study Completion: 2021-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 36

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Part1(Cohort1) : DWJ1521 Amg	Normal saline	-
Part1(Cohort1) : DWJ1521 Amg	DWJ1521	-
Part1(Cohort2) : DWJ1521 Bmg	Normal saline	-
Part1(Cohort2) : DWJ1521 Bmg	DWJ1521	-
Part1(Cohort3) : DWJ1521 Cmg	Normal saline	-
Part1(Cohort3) : DWJ1521 Cmg	DWJ1521	-
Part1(Cohort4) : DWJ1521 Dmg	Normal saline	-
Part2 : DWP14012 Tablet	DWP14012 Tablet	-
Part1(Cohort4) : DWJ1521 Dmg	DWJ1521	-
Part2 : DWJ1521 Xmg	DWJ1521	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of