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

NCT06508645 | Completed Phase 1

• 1 other identifier: DW_DWJ1521102
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (4)

Part1 Treatment Group_1

PLACEBO COMPARATOR

Part1 Treatment Group\_1\_low dose DWP14012 injection Amg, Multiple administration, 7 days Placebo: Normal saline

Drug: DWP14012 injection

Part1 Treatment Group_2

PLACEBO COMPARATOR

Part1 Treatment Group\_2\_medium dose DWP14012 injection Bmg, Multiple administration, 7 days Placebo: Normal saline

Drug: DWP14012 injection

Part1 Treatment Group_3

PLACEBO COMPARATOR

Part1 Treatment Group\_3\_high dose DWP14012 injection Cmg, Multiple administration, 7 days Placebo: Normal saline

Drug: DWP14012 injection

Part2 Treatment Group

EXPERIMENTAL

Part2 Treatment Group\_continuous intravenous administration \- DWP14012 injection Dmg, Loading dose / DWP14012 injection Emg for 3 days, Maintenance dose

Drug: DWP14012 injection

Interventions

DWP14012 injection DRUG

1. 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) 2. Part 2 • Study drug: Daewoong Pharmaceutical Co., Ltd.; DWP14012 inj. (40 mg/vial)

Also known as: Fexuprazan

Part1 Treatment Group_1; Part1 Treatment Group_2; Part1 Treatment Group_3; Part2 Treatment Group

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Daewoong Pharmaceutical Co. LTD.: lead

Study Sites (1)

Seoul-National University Hospital

Seoul, 03080, South Korea

Location

MeSH Terms

Interventions

fexuprazan

Study Officials

• Injin Jang, MD, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2021
• First Posted: July 18, 2024
• Study Start: January 10, 2022
• Primary Completion: March 29, 2022
• Study Completion: April 6, 2022
• Last Updated: July 18, 2024

Record last verified: 2024-07

Locations

KR (1)