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

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04827472

Enrollment

Registered

2021-04-01

Start date

2021-01-20

Completion date

2021-07-31

Last updated

2021-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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.

Interventions

DRUGNormal saline

100ml

DRUGDWJ1521

Single dose

DRUGDWP14012 Tablet

Single dose, Tablet

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

19 Years to 50 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

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]]

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026