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CompletedNCT06508645Updated Jul 18, 2024

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

A Phase 1 interventional study of DWP14012 injection in Healthy Volunteers, sponsored by Daewoong Pharmaceutical Co. LTD.. Completed at 1 site in South Korea. Open to participants aged 19 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-18.

Sponsored by Daewoong Pharmaceutical Co. LTD. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
33
Allocation
Randomized
Ages
19 Years to 50 Years
Sex
All
01

Study 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

02

Conditions studied

  • Healthy Volunteers
03

In context

Lead sponsor

Daewoong Pharmaceutical Co. LTD. is the lead sponsor of 200 studies on the registry; 33 are open to participants now.

Browse Daewoong Pharmaceutical Co. LTD. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
33 participants (actual)

Study arms

  • 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

  • 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

  • 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

  • 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

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)

    Also known as: Fexuprazan

06

What researchers measure

Primary outcomes

  1. AUC0-24h of Fexuprazan

    Pharmacokinetics parameter following DWP14012 injection

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

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

    Parmacodynamics parameter following DWP14012 injection

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

07

Study locations

1 site
  • Seoul-National University Hospital
    Seoul, 03080, South Korea
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2022 to primary completion in Mar 2022, 2 months.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 15, 2021
First posted
Jul 18, 2024
StartActual
Jan 10, 2022
Primary completionActual
Mar 29, 2022
CompletionActual
Apr 6, 2022
Last update
Jul 18, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 18, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06508645
Lead sponsor
Daewoong Pharmaceutical Co. LTD.
Responsible party
Sponsor
First posted
Jul 18, 2024
Start date
Jan 10, 2022
Primary completion
Mar 29, 2022
Completion
Apr 6, 2022
Last update
Jul 18, 2024

Study contacts

Injin Jang, MD, PhD
principal investigator · Seoul National University Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Fexuprazan

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