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

NCT04827472 — Phase 1, Unknown, 36 participants, Daewoong Pharmaceutical Co. LTD.

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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

Registry	NCT04827472
Status	Unknown
Phase	Phase 1
Study type	Interventional; randomized, parallel, masking: double, treatment
Enrollment	36 (Estimated)
Sponsor	Daewoong Pharmaceutical Co. LTD. (Industry)
Conditions	Healthy
Interventions	Normal saline, DWJ1521, DWP14012 Tablet (Drug)
Dates	start 2021-01-20, primary completion 2021-06-30 (estimated), completion 2021-07-31 (estimated), first posted 2021-04-01, last updated 2021-06-10
Locations	1 site in South Korea

-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.

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+Arms and interventions

Arm	Type	Interventions
Part1(Cohort1) : DWJ1521 Amg	Experimental	Drug: Normal saline; Drug: DWJ1521
Part1(Cohort2) : DWJ1521 Bmg	Experimental	Drug: Normal saline; Drug: DWJ1521
Part1(Cohort3) : DWJ1521 Cmg	Experimental	Drug: Normal saline; Drug: DWJ1521
Part1(Cohort4) : DWJ1521 Dmg	Experimental	Drug: Normal saline; Drug: DWJ1521
Part2 : DWJ1521 Xmg	Experimental	Drug: DWJ1521
Part2 : DWP14012 Tablet	Experimental	Drug: DWP14012 Tablet

Normal saline (Drug): 100ml
DWJ1521 (Drug): Single dose
DWP14012 Tablet (Drug): Single dose, Tablet

+Outcome measures

Primary outcomes

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

+Eligibility

Sex: All, ages: 19 Years to 50 Years, 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.

+Locations (1)

Facility	City	Country	Status
Seoul National University Hospital	Seoul	South Korea	Recruiting