## Protocol Section
### Identification Module
**NCT ID:** NCT06427590

**Brief Title:** Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASC47 in Healthy Subjects

**Official Title:** A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Dose Escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASC47 Injection for Subcutaneous Use in Healthy Subjects

#### Organization Study ID Info
**ID:** ASC47-101
#### Organization
**Class:** INDUSTRY
**Full Name:** Gannex Pharma Co., Ltd.
### Status Module
#### Completion Date
**Date:** 2025-04

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-24

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-12

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-10
**Study First Submit QC Date:** 2024-05-19
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Gannex Pharma Co., Ltd.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Is US Export:** False

### Description Module

**Brief Summary:** This will be a phase I, randomized, double-blind, placebo-controlled, single-dose escalation study. This study will be conducted in three periods: the screening period , the treatment period and the follow-up period.

This study aims to evaluate the pharmacokinetics, target engagement and pharmacodynamic biomarkers of ASC47 in healthy subjects.

**Detailed Description:** The study will consist of five cohorts, each with different doses of ASC47. Cohorts 1 and 2 have 6 subjects, of which 4 subjects will receive the single dose of ASC47 and 2 subjects will receive matching placebo. Cohorts 3, 4 and 5 have 8 subjects, of which 6 subjects will receive the single dose of ASC47 and 2 subjects will receive matching placebo.

### Conditions Module

**Conditions:**

- NASH

**Keywords:**

- ASC47

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** SEQUENTIAL

##### Masking Info

**Masking:** TRIPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 36

**Type:** ESTIMATED

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 4 subjects will receive the dose 1 of ASC47, and 2 subjects will receive the placebo.

**Intervention Names:**

- Drug: ASC47

- Drug: Matching placebo

**Label:** cohort 1

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** 4 subjects will receive the dose 2 of ASC47, and 2 subjects will receive the placebo.

**Intervention Names:**

- Drug: ASC47

- Drug: Matching placebo

**Label:** cohort 2

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** 6 subjects will receive the dose 3 of ASC47, and 2 subjects will receive the placebo.

**Intervention Names:**

- Drug: ASC47

- Drug: Matching placebo

**Label:** cohort 3

**Type:** EXPERIMENTAL

#### Arm Group 4

**Description:** 6 subjects will receive the dose 4 of ASC47, and 2 subjects will receive the placebo.

**Intervention Names:**

- Drug: ASC47

- Drug: Matching placebo

**Label:** cohort 4

**Type:** EXPERIMENTAL

#### Arm Group 5

**Description:** 6 subjects will receive the dose 5 of ASC47, and 2 subjects will receive the placebo

**Intervention Names:**

- Drug: ASC47

- Drug: Matching placebo

**Label:** cohort 5

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- cohort 1

- cohort 2

- cohort 3

- cohort 4

- cohort 5

**Description:** single subcutaneous injection of ASC47

**Name:** ASC47

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- cohort 1

- cohort 2

- cohort 3

- cohort 4

- cohort 5

**Description:** single subcutaneous injection of Placebo

**Name:** Matching placebo

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Evaluate the incidence of Serious Adverse Events (SAEs) and Adverse Events (AEs) from after the first dose administration to 57 days.

**Measure:** Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

**Time Frame:** up to 57 days

**Description:** Evaluate the ECG QT Interval after single doses of ASC47.

**Measure:** ECG QT Interval

**Time Frame:** up to 57 days

**Description:** Evaluate red blood cell count, white blood cell count and platelet count in liter (cells/L) after single doses of ASC47.

**Measure:** Blood cell

**Time Frame:** up to 57 days

**Description:** Evaluate the levels of glucose, cholesterol, electrolytes after single doses of ASC47.

**Measure:** Hematology

**Time Frame:** up to 57 days

#### Secondary Outcomes

**Description:** Evaluate the Area under the plasma concentration versus time curve after single doses of ASC47.

**Measure:** AUC of ASC47

**Time Frame:** up to 57 days

**Description:** Evaluate the Peak Plasma Concentration after single doses of ASC47.

**Measure:** Cmax of ASC47

**Time Frame:** up to 57 days

**Description:** Evaluate the Minimum Plasma Concentration after single doses of ASC47.

**Measure:** Cmin of ASC47

**Time Frame:** up to 57 days

**Description:** Evaluate the Terminal-Phase Half-Life after single doses of ASC47

**Measure:** T1/2 of ASC47

**Time Frame:** up to 57 days

**Description:** Evaluate the Apparent Systemic Clearance after single doses of ASC47.

**Measure:** CL/F of ASC47

**Time Frame:** up to 57 days

**Description:** Evaluate the Apparent Volume of Distribution after single doses of ASC47.

**Measure:** Vd/F of ASC47

**Time Frame:** up to 57 days

**Description:** Evaluate the LDL-C, TG, TC, HDL-C after single doses of ASC47.

**Measure:** Lipid parameters

**Time Frame:** up to 57 days

### Eligibility Module

**Eligibility Criteria:** Key inclusion Criteria:

* Subject have provided informed consent before initiation of any study-specific procedures
* Healthy male subjects or female subjects, between 18 and 55 years of age (inclusive).
* Females who are not pregnant or breastfeeding, or do not plan to become pregnant within 6 months and are willing to use effective contraceptive measures from the first dose of the investigational product until 3 months after the last dose are eligible.
* In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and other screening procedures, eg.

Key exclusion Criteria:

* Have a clinically relevant acute or chronic medical condition or disease of the cardiovascular, gastrointestinal, hepatic, renal, endocrine, pulmonary, neurologic, or dermatologic systems as assessed by the investigator.
* Have any current or historical disease or disorder of the hematological system or significant liver disease or family history of bleeding/platelet disorders.
* Have a history of cancer (other than basal cell or squamous cell cancer of the skin which is fully excised), rheumatologic disease or blood dyscrasia.
* Have a history of febrile illness within 14 days prior to screening.
* Have a positive alcohol or drug screen at Screening or have a history of alcohol or drug abuse within the past 1 years.
* Have an autoimmune disease, is immunosuppressed or is in any way immunocompromised.
* Have used prescription drugs (other than hormone replacement therapy and medications for contraceptive purpose) within 14 days prior to the first dose of Investigational product.

**Healthy Volunteers:** True

**Maximum Age:** 55 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-31
