Skip to main content
OpenTrials
Completed

NCT Number: NCT06508645

Study to Evaluate the Safety/Tolerability, PK and PD After Intravenous DWJ1521 Administration in Healthy Volunteers

A randomized, double-blind, placebo-controlled, multiple-dose clinical trial to evaluate the safety/tolerability and pharmacokinetics, and pharmacodynamics after intravenous DWP14012 injection in healthy volunteers

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

19 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Seoul-National University Hospital

Seoul, 03080, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy adults aged ≥ 19 and ≤ 50 years at screening
  • Subjects with a body weight of ≥ 55.0 kg to ≤ 90.0 kg with a body mass index (BMI) of ≥ 18.0 and ≤ 28.0 at screening

☞ BMI(kg/m2) = weight (kg) / {Height (m)}2

  • Subjects who have given written consent on voluntary decision of participation prior to the screening procedure after being fully informed of and completely understanding this study
  • Subjects eligible to participate in the study at the discretion of the investigator by physical examination, laboratory tests, investigator questioning, etc.

Exclusion criteria

  • Present or prior history of clinically significant hepatic, renal, nervous system, immune, respiratory, and endocrine diseases, hematologic and oncologic diseases, cardiovascular diseases, or mental diseases
  • Gastrointestinal diseases (gastric ulcer, gastritis, gastric cramps, gastroesophageal reflux, Crohn's disease, etc.) that may affect the safety and pharmacokinetic evaluation results of investigational drugs and those with a history of gastrointestinal surgery (except for appendix surgery and hernia surgery alone).
  • Helicobacter pylori positive.

Treatment and study plan

DWP14012 injection

Drug
  • Part 1
  • Study drug: Daewoong Pharmaceutical Co., Ltd.; A mg, B mg, and C mg of DWP14012 inj. (40 mg/vial)
  • Control drug: Placebo (Normal saline)
  • Part 2 • Study drug: Daewoong Pharmaceutical Co., Ltd.; DWP14012 inj. (40 mg/vial)

Other names: Fexuprazan

Primary outcomes

  1. AUC0-24h of Fexuprazan

    Time frame: Part1 for 8 days, Part2 for 5 days

    Pharmacokinetics parameter following DWP14012 injection

  2. 24h pH monitoring, the ratio of the time remaining above pH 4, 6 (time%)

    Time frame: Part1 for 8 days, Part2 for 4 days

    Parmacodynamics parameter following DWP14012 injection

Sponsors and collaborators

Lead sponsor

Daewoong Pharmaceutical Co. LTD.

Industry

Registry information

Official study title

A Randomized, Double-blind, Placebo-controlled, Multiple-dose Clinical Trial to Evaluate the Safety/Tolerability and Pharmacokinetics, and Pharmacodynamics After Intravenous DWP14012 Injection in Healthy Volunteers

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jul 18, 2024
Registry last updated
Jul 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.