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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: DWP14012 injection

• Registration Number: NCT06508645
• Lead Sponsor: Daewoong Pharmaceutical Co. LTD.

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-15
• Study Start: 2022-01-10
• Primary Completion: 2022-03-29
• Study Completion: 2022-04-06
• Status Verified: 2024-07
• Study First Submitted QC: 2024-07-12
• Last Update Submitted: 2024-07-12
• Study First Posted: 2024-07-18
• Last Update Posted: 2024-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Part1 Treatment Group_2	DWP14012 injection	Part1 Treatment Group_2_medium dose DWP14012 injection Bmg, Multiple administration, 7 days Placebo: Normal saline
Part1 Treatment Group_3	DWP14012 injection	Part1 Treatment Group_3_high dose DWP14012 injection Cmg, Multiple administration, 7 days Placebo: Normal saline
Part2 Treatment Group	DWP14012 injection	Part2 Treatment Group_continuous intravenous administration - DWP14012 injection Dmg, Loading dose / DWP14012 injection Emg for 3 days, Maintenance dose
Part1 Treatment Group_1	DWP14012 injection	Part1 Treatment Group_1_low dose DWP14012 injection Amg, Multiple administration, 7 days Placebo: Normal saline

Primary Outcome Measures

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

Trial Locations

Locations (1)

Seoul-National University Hospital; 🇰🇷 Seoul, Korea, Republic of