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

Sponsor

Daewoong Pharmaceutical Co. LTD. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04827472

Collaborator

(none)

Enrollment

Location

Arms

6.3

Anticipated Duration (Months)

5.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Normal saline Drug: DWJ1521 Drug: DWP14012 Tablet	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 20, 2021

Anticipated Primary Completion Date :

Jun 30, 2021

Anticipated Study Completion Date :

Jul 31, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

Daewoong Pharmaceutical Co. LTD.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Daewoong Pharmaceutical Co. LTD.

ClinicalTrials.gov Identifier:

NCT04827472

Other Study ID Numbers:

DW_DWJ1521101

First Posted:

Apr 1, 2021

Last Update Posted:

Jun 10, 2021

Last Verified:

Mar 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jun 10, 2021