to Evaluate the Safety/Tolerability and Pharmacokinetics, and Pharmacodynamics of DWP14012 Injection

Daewoong Pharmaceutical

Status and phase: Not yet enrolling; Phase 1

Conditions: Erosive Gastroesophageal Reflux Disease

Treatments: Drug: Fexuprazan Injection_part 3; Drug: Fexuprazan Injection placebo; Drug: Fexuprazan tablet; Drug: Fexuprazan Injection_part 2; Drug: Fexuprazan Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT06437951

DW_DWJ1521104

Details and patient eligibility

About

to evaluate the safety/tolerability and pharmacokinetics, and pharmacodynamics after intravenous DWP14012 injection in healthy participants

Enrollment: 40 estimated patients

Sex: All

Ages: 19 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy adult volunteers aged 19 to 50 at the time of screening tests
2. Those who weigh more than 50.0 kg, 90.0 kg or less, and have a BMI of 18.5 or more and 29.9 or less at the time of screening inspection BMI (kg/m2) = Weight (kg) / {Height (m)}2
3. In the case of female volunteers, those who are not necessarily pregnant or lactating or who are in surgical infertility (bilateral ovarian obstruction, hysterectomy, bilateral ovarian resection, etc.)
4. A person who voluntarily decides to participate after hearing and fully understanding the detailed explanation of this clinical trial and agrees in writing before a screening procedure
5. A person who is suitable for this test when judging the tester by physical examination, clinical laboratory examination, questionnaire, etc

Exclusion criteria

1. Clinically significant hepatomegaly (severe liver disorder, viral hepatitis, etc.), kidney (severe renal disorder, etc.), nervous system, immune system, respiratory system, digestive system, endocrine system, blood and tumor, cardiovascular system (heart failure, Torsades de points, etc.), urinary system, mental system (fever disorder, obsessive compulsive disorder, etc.), sexual dysfunction, etc
2. A person who has a history of gastrointestinal diseases (such as Crohn's disease, ulcers, gastritis, gastritis, gastroesophageal reflux disease, etc.) or surgery (except simple appendectomy or hernia) that may affect the safety, pharmacokinetics and pharmacodynamic evaluation of clinical medicines
3. Those with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
4. A person who has been tested positive for Helicobacter pylori
5. Those who have anatomical impairments in insertion and maintenance of the pH meter catheter etc

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 5 patient groups, including a placebo group

Part1_test group

Experimental group

Description:

IV injection of test drugs by dose group

Treatment:

Drug: Fexuprazan Injection

Part1_placebo group

Placebo Comparator group

Description:

IV injection of test drugs by dose group

Treatment:

Drug: Fexuprazan Injection placebo

Part2

Experimental group

Description:

All Participants take IV injection of test drugs

Treatment:

Drug: Fexuprazan Injection_part 2

Part3_test group

Experimental group

Description:

In the case of test group, take IV injection in the period 1 and take a tablet in the period 2

Treatment:

Drug: Fexuprazan tablet

Drug: Fexuprazan Injection_part 3

Part3_reference group

Active Comparator group

Description:

In the case of reference group, take a tablet in the period 1 and take IV injection in the period 2

Treatment:

Drug: Fexuprazan tablet

Drug: Fexuprazan Injection_part 3