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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy
• Intervention / Treatment: Drug: Normal saline; Drug: DWJ1521; Drug: DWP14012 Tablet

• Study Type: Interventional
• Enrollment (Anticipated): 36
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Seoul National University Hospital
    • Contact: Injin Jang; Phone Number: 82-2-2072-1666; Email: ijjang@snu.ac.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Part1(Cohort1) : DWJ1521 Amg	Drug: Normal saline; 100ml; Drug: DWJ1521; Single dose
EXPERIMENTAL: Part1(Cohort2) : DWJ1521 Bmg	Drug: Normal saline; 100ml; Drug: DWJ1521; Single dose
EXPERIMENTAL: Part1(Cohort3) : DWJ1521 Cmg	Drug: Normal saline; 100ml; Drug: DWJ1521; Single dose
EXPERIMENTAL: Part1(Cohort4) : DWJ1521 Dmg	Drug: Normal saline; 100ml; Drug: DWJ1521; Single dose
EXPERIMENTAL: Part2 : DWJ1521 Xmg	Drug: DWJ1521; Single dose
EXPERIMENTAL: Part2 : DWP14012 Tablet	Drug: DWP14012 Tablet; Single dose, Tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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]]

Collaborators and Investigators

• Sponsor: Daewoong Pharmaceutical Co. LTD.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 20, 2021
• Primary Completion (ANTICIPATED): June 30, 2021
• Study Completion (ANTICIPATED): July 31, 2021

Study Registration Dates

• First Submitted: March 25, 2021
• First Submitted That Met QC Criteria: March 30, 2021
• First Posted (ACTUAL): April 1, 2021

Study Record Updates

• Last Update Posted (ACTUAL): June 10, 2021
• Last Update Submitted That Met QC Criteria: June 8, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: DW_DWJ1521101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No