## Protocol Section
### Identification Module
**NCT ID:** NCT06437951

**Brief Title:** to Evaluate the Safety/Tolerability and Pharmacokinetics, and Pharmacodynamics of DWP14012 Injection

**Official Title:** A Randomized, Double-blind, Placebo-controlled, Single/Multiple-dose, Phase 1 Clinical Trial to Evaluate the Safety/Tolerability and Pharmacokinetics, and Pharmacodynamics After Intravenous DWP14012 Injection in Healthy Participants

#### Organization Study ID Info
**ID:** DW_DWJ1521104
#### Organization
**Class:** INDUSTRY
**Full Name:** Daewoong Pharmaceutical Co. LTD.
### Status Module
#### Completion Date
**Date:** 2025-05

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-29

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-07

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-13
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Daewoong Pharmaceutical Co. LTD.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

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

### Conditions Module

**Conditions:**

- Erosive Gastroesophageal Reflux Disease

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 40

**Type:** ESTIMATED

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** IV injection of test drugs by dose group

**Intervention Names:**

- Drug: Fexuprazan Injection

**Label:** Part1_test group

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** IV injection of test drugs by dose group

**Intervention Names:**

- Drug: Fexuprazan Injection placebo

**Label:** Part1_placebo group

**Type:** PLACEBO_COMPARATOR

#### Arm Group 3

**Description:** All Participants take IV injection of test drugs

**Intervention Names:**

- Drug: Fexuprazan Injection_part 2

**Label:** Part2

**Type:** EXPERIMENTAL

#### Arm Group 4

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

**Intervention Names:**

- Drug: Fexuprazan Injection_part 3

- Drug: Fexuprazan tablet

**Label:** Part3_test group

**Type:** EXPERIMENTAL

#### Arm Group 5

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

**Intervention Names:**

- Drug: Fexuprazan Injection_part 3

- Drug: Fexuprazan tablet

**Label:** Part3_reference group

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Part1_test group

**Description:** 20/40/80 mg

**Name:** Fexuprazan Injection

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Part1_placebo group

**Description:** 20/40/80 mg

**Name:** Fexuprazan Injection placebo

**Type:** DRUG

#### Intervention 3

**Arm Group Labels:**

- Part2

**Description:** 20mg

**Name:** Fexuprazan Injection_part 2

**Type:** DRUG

#### Intervention 4

**Arm Group Labels:**

- Part3_reference group

- Part3_test group

**Description:** 40mg

**Name:** Fexuprazan Injection_part 3

**Type:** DRUG

#### Intervention 5

**Arm Group Labels:**

- Part3_reference group

- Part3_test group

**Description:** 40mg

**Name:** Fexuprazan tablet

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** 1. Blood and urinary concentrations of Fexuprazan by part

**Measure:** PK of Fexuprazan

**Time Frame:** 0 and 72hour

**Description:** 1. Blood and urinary concentrations of metabolite by part

**Measure:** PK of metabolite

**Time Frame:** 0 and 72hour

**Description:** pH monitoring

**Measure:** PD of Fexuprazan

**Time Frame:** up to 15days

### Eligibility Module

**Eligibility Criteria:** 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

**Healthy Volunteers:** True

**Maximum Age:** 50 Years

**Minimum Age:** 19 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** leesj0323@snu.ac.kr

**Name:** Sujong Lee, Ph.D

**Phone:** 027408910

**Role:** CONTACT

#### Overall Officials

**Official 1:**

**Affiliation:** Seoul National University College of Medicine and Hospital

**Name:** Injin zhang, Ph.D

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000015154

- Term: Esophageal Motility Disorders

- ID: D000003680

- Term: Deglutition Disorders

- ID: D000004935

- Term: Esophageal Diseases

- ID: D000005767

- Term: Gastrointestinal Diseases

- ID: D000004066

- Term: Digestive System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC09

- Name: Ear, Nose, and Throat Diseases

### Condition Browse Module - Browse Leaves

- ID: M8880

- Name: Gastroesophageal Reflux

- Relevance: HIGH

- As Found: Gastroesophageal Reflux

- ID: M17874

- Name: Esophageal Motility Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M17875

- Name: Esophageal Spasm, Diffuse

- Relevance: LOW

- As Found: Unknown

- ID: M6882

- Name: Deglutition Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M8085

- Name: Esophageal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000005764

- Term: Gastroesophageal Reflux

### Intervention Browse Module - Ancestors

- ID: D000005765

- Term: Gastrointestinal Agents

### Intervention Browse Module - Browse Branches

- Abbrev: Gast

- Name: Gastrointestinal Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M350719

- Name: Fexuprazan

- Relevance: HIGH

- As Found: Transverse abdominal

- ID: M8881

- Name: Gastrointestinal Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: C000634065

- Term: Fexuprazan

### Misc Info Module

- Version Holder: 2024-05-31
