## Protocol Section
### Identification Module
**NCT ID:** NCT05089279

**Brief Title:** Study to Evaluate the Safety and Pharmacokinetics of CKD-349 in Healthy Adult Volunteers

**Official Title:** An Open Label, Randomized, Single-dose, 2-sequence, 2-period, Cross-over Phase 1 Study to Evaluate the Safety and Pharmacokinetics of CKD-349 in Healthy Adult Volunteers

#### Organization Study ID Info
**ID:** A111_01BE2019
#### Organization
**Class:** INDUSTRY
**Full Name:** Chong Kun Dang Pharmaceutical
### Status Module
#### Completion Date
**Date:** 2022-04-06

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-10-07

**Type:** ACTUAL

**Last Update Submit Date:** 2022-10-05

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2022-01-18

**Type:** ACTUAL

#### Start Date
**Date:** 2021-11-03

**Type:** ACTUAL

**Status Verified Date:** 2021-12

#### Study First Post Date
**Date:** 2021-10-22
**Type:** ACTUAL
**Study First Submit Date:** 2021-10-14
**Study First Submit QC Date:** 2021-10-14
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Chong Kun Dang Pharmaceutical

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Study to Evaluate the Safety and Pharmacokinetics of CKD-349

**Detailed Description:** An Open Label, Randomized, Single-dose, 2-sequence, 2-period, Cross-over Phase 1 Study to Evaluate the Safety and Pharmacokinetics of CKD-349 in Healthy Adult Volunteers

### Conditions Module

**Conditions:**

- Chronic Heart Failure

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** CROSSOVER

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 71

**Type:** ACTUAL

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Period 1: D113/ Period 2: CKD-349

**Intervention Names:**

- Drug: D113

- Drug: CKD-349

**Label:** Sequence 1

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Period 1: CKD-349/ Period 2: D113

**Intervention Names:**

- Drug: D113

- Drug: CKD-349

**Label:** Sequence2

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Sequence 1

- Sequence2

**Description:** QD, PO

**Name:** D113

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Sequence 1

- Sequence2

**Description:** QD, PO

**Name:** CKD-349

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** AUCt: Area under the concentration-time curve from time zero to time

**Measure:** AUCt of CKD-349

**Time Frame:** 0, 0.08, 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 hours

**Description:** Cmax: Maximum plasma concentration of the drug

**Measure:** Cmax of CKD-349

**Time Frame:** 0, 0.08, 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 hours

#### Secondary Outcomes

**Description:** Area under the concentration-time curve from zero up to ∞

**Measure:** AUCinf of CKD-349

**Time Frame:** 0, 0.08, 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 hours

**Description:** Time to maximum plasma concentration

**Measure:** Tmax of CKD-349

**Time Frame:** 0, 0.08, 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 hours

**Description:** AUCt/AUCinf

**Measure:** AUCt/AUCinf of CKD-349

**Time Frame:** 0, 0.08, 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 hours

**Description:** Terminal elimination half-life

**Measure:** T1/2 of CKD-349

**Time Frame:** 0, 0.08, 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 hours

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Healthy adult volunteers aged ≥ 19 years
2. Weight ≥50kg (man) or 45kg (woman), with calculated body mass index (BMI) of 18 to 30 kg/m2
3. Those who have no congenital diseases or chronic diseases and have no abnormal symptoms or findings.
4. Those who are eligible for clinical trials based on laboratory (hematology, blood chemistry, serology, urology) and 12-lead ECG results at screening.
5. Those who agree to contraception until 7 days after clinical trial.
6. Individuals who voluntarily decide to participate and agree to comply with the cautions after fully understand the detailed description of this clinical trial.

Exclusion Criteria:

1. Those who have clinically significant diseases or history in digestive systems, cardiovascular system, endocrine system, respiratory system, blood·tumor, infectious disease, kidney and urogenital system, mental·nervous system, musculoskeletal system, immune system, otolaryngology, skin system, ophthalmology system, etc.
2. Those who have a history of gastrointestinal surgery except simple appendectomy and hernia surgery.
3. Those who take barbiturate and any related drugs which may cause induction or inhibition of drug metabolism within 1 month before the first administration of investigational products or take drugs that may interfere with this clinical trials within 10 day before the first administration
4. Those who received investigational products or participated in bioequivalence tests within 6 months before the first administration of clinical trial drugs.
5. Those who donated whole blood within 8 weeks or donated ingredients within 2 weeks, or received a blood transfusion within 4 weeks.
6. Those who exceed an alcohol and cigarette consumption than below criteria A. Alcohol: Man- 21 glasses/week, Woman - 14 glasses/week (1 glass: Soju 50mL, Wine 30mL, or beer 250mL) B. Smoking: 20 cigarettes/day
7. Those who overreacts to the ingredient of this drug and is administering an angiotensin conversion enzyme (ACE) inhibitor or has not passed 36 hours since discontinuation of administration and has a history of vascular edema when administering an angiotensin conversion enzyme (ACE) inhibitor or an angiotensin receptor antagonist (ARB).
8. Those who are deemed insufficient to participate in this clinical study by investigators.
9. Woman who are pregnant or breastfeeding.

**Healthy Volunteers:** True

**Minimum Age:** 19 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Seoul

**Country:** Korea, Republic of

**Facility:** H Plus Yangji Hospital

**State:** Gwanak-gu

**Zip:** 08779

#### Overall Officials

**Official 1:**

**Affiliation:** Study Principal Investigator

**Name:** JaeWoo Kim

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000006331

- Term: Heart Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M9421

- Name: Heart Failure

- Relevance: HIGH

- As Found: Heart Failure

- ID: M9419

- Name: Heart Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

- ID: T4202

- Name: Oculocerebral Syndrome With Hypopigmentation

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000006333

- Term: Heart Failure

### Misc Info Module

- Version Holder: 2024-05-24
