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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06508645

Enrollment

Registered

2024-07-18

Start date

2022-01-10

Completion date

2022-04-06

Last updated

2024-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

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

Interventions

DRUGDWP14012 injection

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)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

19 Years to 50 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026