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
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 33
- Locations
- 1
- Primary Endpoint
- AUC0-24h of Fexuprazan
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 19 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
Part1 Treatment Group_1
Part1 Treatment Group_1_low dose DWP14012 injection Amg, Multiple administration, 7 days
Placebo: Normal saline
Intervention: DWP14012 injection (Drug)
Part1 Treatment Group_2
Part1 Treatment Group_2_medium dose DWP14012 injection Bmg, Multiple administration, 7 days
Placebo: Normal saline
Intervention: DWP14012 injection (Drug)
Part1 Treatment Group_3
Part1 Treatment Group_3_high dose DWP14012 injection Cmg, Multiple administration, 7 days
Placebo: Normal saline
Intervention: DWP14012 injection (Drug)
Part2 Treatment Group
Part2 Treatment Group_continuous intravenous administration
- DWP14012 injection Dmg, Loading dose / DWP14012 injection Emg for 3 days, Maintenance dose
Intervention: DWP14012 injection (Drug)
Outcomes
Primary Outcomes
AUC0-24h of Fexuprazan
Time Frame: 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%)
Time Frame: Part1 for 8 days, Part2 for 4 days
Parmacodynamics parameter following DWP14012 injection
Secondary Outcomes
No secondary outcomes reported