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

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

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: DWP14012 injection

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Seoul-National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Healthy adults aged ≥ 19 and ≤ 50 years at screening

2. 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

3. 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
4. Subjects eligible to participate in the study at the discretion of the investigator by physical examination, laboratory tests, investigator questioning, etc.

Exclusion Criteria:

1. 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
2. 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).
3. Helicobacter pylori positive.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Part1 Treatment Group_1; Part1 Treatment Group_1_low dose DWP14012 injection Amg, Multiple administration, 7 days Placebo: Normal saline	Drug: DWP14012 injection; Part 1Study 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
Placebo Comparator: Part1 Treatment Group_2; Part1 Treatment Group_2_medium dose DWP14012 injection Bmg, Multiple administration, 7 days Placebo: Normal saline	Drug: DWP14012 injection; Part 1Study 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
Placebo Comparator: Part1 Treatment Group_3; Part1 Treatment Group_3_high dose DWP14012 injection Cmg, Multiple administration, 7 days Placebo: Normal saline	Drug: DWP14012 injection; Part 1Study 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
Experimental: Part2 Treatment Group; Part2 Treatment Group_continuous intravenous administration - DWP14012 injection Dmg, Loading dose / DWP14012 injection Emg for 3 days, Maintenance dose	Drug: DWP14012 injection; Part 1Study 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC0-24h of Fexuprazan	Pharmacokinetics parameter following DWP14012 injection	Part1 for 8 days, Part2 for 5 days
24h pH monitoring, the ratio of the time remaining above pH 4, 6 (time%)	Parmacodynamics parameter following DWP14012 injection	Part1 for 8 days, Part2 for 4 days

Collaborators and Investigators

• Sponsor: Daewoong Pharmaceutical Co. LTD.
• Investigators: Principal Investigator: Injin Jang, MD, PhD, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2022
• Primary Completion (Actual): March 29, 2022
• Study Completion (Actual): April 6, 2022

Study Registration Dates

• First Submitted: December 15, 2021
• First Submitted That Met QC Criteria: July 12, 2024
• First Posted (Actual): July 18, 2024

Study Record Updates

• Last Update Posted (Actual): July 18, 2024
• Last Update Submitted That Met QC Criteria: July 12, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Gastrointestinal Agents; Fexuprazan
• Other Study ID Numbers: DW_DWJ1521102

Drug and device information, study documents

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