## Protocol Section
### Identification Module
**NCT ID:** NCT04255979

**Brief Title:** A Study of HY209 in Healthy Male Volunteers for Sepsis

**Official Title:** A Randomized, Double-blind, Placebo-controlled Single Dosing, Dose Escalation Phase I Clinical Trial to Investigate the Safety/Tolerability and Pharmacokinetics of HY209 After Intravenous Administration in Healthy Male Volunteers

#### Organization Study ID Info
**ID:** HY209-IV
#### Organization
**Class:** INDUSTRY
**Full Name:** Shaperon
### Status Module
#### Completion Date
**Date:** 2020-06-12

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2020-11-30

**Type:** ACTUAL

**Last Update Submit Date:** 2020-11-27

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2020-06-12

**Type:** ACTUAL

#### Start Date
**Date:** 2019-12-05

**Type:** ACTUAL

**Status Verified Date:** 2020-11

#### Study First Post Date
**Date:** 2020-02-05
**Type:** ACTUAL
**Study First Submit Date:** 2020-02-03
**Study First Submit QC Date:** 2020-02-03
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Shaperon

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** A randomized, double-blind, placebo-controlled single dosing, dose escalation phase I clinical trial to investigate the safety/tolerability and pharmacokinetics of HY209 after intravenous administration in healthy male volunteers

**Detailed Description:** HY209, which is being developed for the treatment of sepsis, inhibits inflammation by promoting the differentiation and division of Myeloid-derived suppressor cells (MDSCs).

### Conditions Module

**Conditions:**

- Sepsis

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** Randomized, double-blind, placebo-controlled single dosing, dose escalation

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 40

**Type:** ACTUAL

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Single dose of HY209 0.1 mg/kg or placebo.

**Intervention Names:**

- Drug: HY209

**Label:** Cohort 1

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Single dose of HY209 0.2 mg/kg or placebo.

**Intervention Names:**

- Drug: HY209

**Label:** Cohort 2

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** Single dose of HY209 0.4 mg/kg or placebo.

**Intervention Names:**

- Drug: HY209

**Label:** Cohort 3

**Type:** EXPERIMENTAL

#### Arm Group 4

**Description:** Single dose of HY209 0.8 mg/kg or placebo.

**Intervention Names:**

- Drug: HY209

**Label:** Cohort 4

**Type:** EXPERIMENTAL

#### Arm Group 5

**Description:** Single dose of HY209 1.6 mg/kg or placebo.

**Intervention Names:**

- Drug: HY209

**Label:** Cohort 5

**Type:** EXPERIMENTAL

#### Arm Group 6

**Description:** Single dose of HY209 3.2 mg/kg or placebo.

**Intervention Names:**

- Drug: HY209

**Label:** Cohort 6

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Cohort 1

- Cohort 2

- Cohort 3

- Cohort 4

- Cohort 5

- Cohort 6

**Description:** 6 Subjects will be assigned to drug (HY209) and 2 subjects will be assigned to placebo.

**Name:** HY209

**Other Names:**

- HY209-IV

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Number of subjects with abnormal laboratory values and/or adverse events that are related to treatment

**Measure:** Incidence of treatment emergent adverse events (TEAEs)

**Time Frame:** Up to Day 6

#### Secondary Outcomes

**Description:** Maximum concentration of HY209 in plasma

**Measure:** Maximum concentration (Cmax) of HY209

**Time Frame:** Up to Day 2

**Description:** Area under the plasma HY209 concentration-time curve over the time interval from 0 extrapolated to infinity

**Measure:** Ratio of area under curve infinity (AUCinf) of HY209

**Time Frame:** Up to Day 2

**Description:** Area under the plasma HY209 concentration-time curve over the time interval from 0 to the last quantifiable plasma concentration

**Measure:** Ratio of area under curve last (AUClast) of HY209

**Time Frame:** Up to Day 2

**Description:** Time of maximum concentration of HY209 in plasma

**Measure:** Time of maximum concentration (Tmax) of HY209

**Time Frame:** Up to Day 2

**Description:** Terminal half-life of HY209 in plasma

**Measure:** Terminal halif-life (t1/2) of HY209

**Time Frame:** Up to Day 2

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Healthy male aged from 19 to 45 at screening test
* BMI 18 kg/m2 \~ 27 kg/m2 at screening test
* Subjects found to be clinically healthy by medical history, physical examination, vital signs, electrocardiogram (ECG), and appropriate laboratory tests
* Those who must be capable of giving informed consent and willing to comply with all clinic visits and study-related procedures for the duration of study until study completion

Exclusion Criteria:

* Those who have a history of hypersensitivity or clinically significant hypersensitivity reactions to drugs (containing Taurodeoxycholate component, aspirin, antibiotics, etc.)
* Those who showed clinical symptoms suspected of acute infectious disease within 2 weeks before the first does, or whose body temperature (ear canal) measured at screening showed 38 ℃ or higher
* Those who have a clinically significant disease of liver, kidney, digestive, respiratory, endocrine, neurologic, blood/tumor, cardiovascular system history of those diseases
* Those who have a history of gastrointestinal diseases or surgery that may affect the absorption of the investigational drug
* Those who have a history of substance abuse or have tested positive for drugs of concern for misuse by urine drug screening
* Patients with the following blood pressure measured at the seat after resting for more than 5 minutes at the screening visit \[Systolic blood pressure (SBP): \< 90 mmHg or \> 150 mmHg, Diastolic blood pressure (DBP): \< 50 mmHg or \> 90 mmHg\]
* Those who participated in other clinical trials or bioequivalence within 6 months prior to the first dosing and received the drug
* Those who have donated whole blood within 2 months before the first dose or ingredient donation within 1 month or received blood transfusion within 1 month
* Those who have taken metabolic enzyme-induced and inhibitory drugs within 1 month before screening
* Those who consumed grapefruit / caffeine-containing foods within 3 days of the first dose and who cannot refrain from eating grapefruit-containing foods from 3 days before admission to discharge date
* Those who have taken specialty or herbal medicines within 2 weeks of the first dose or who have taken over-the-counter (OTC) within 1 week
* Caffeine overdose, alcohol overdose or oversmoker
* Those who have unusual eating habits or who are unable to eat the meals provided in this clinical trial
* Other investigator judged to be unsuitable as clinical subject

**Healthy Volunteers:** True

**Maximum Age:** 45 Years

**Minimum Age:** 19 Years

**Sex:** MALE

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Seoul

**Country:** Korea, Republic of

**Facility:** Seoul National University Hospital

**State:** Jongno-gu

**Zip:** 03080

#### Overall Officials

**Official 1:**

**Affiliation:** Seoul National University Hospital

**Name:** In-jin Jang

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007239

- Term: Infections

- ID: D000018746

- Term: Systemic Inflammatory Response Syndrome

- ID: D000007249

- Term: Inflammation

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M20864

- Name: Sepsis

- Relevance: HIGH

- As Found: Sepsis

- ID: M16869

- Name: Toxemia

- Relevance: LOW

- As Found: Unknown

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M16355

- Name: Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M20818

- Name: Systemic Inflammatory Response Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M10293

- Name: Inflammation

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000018805

- Term: Sepsis

### Misc Info Module

- Version Holder: 2024-05-24
