## Protocol Section
### Identification Module
**NCT ID:** NCT06428903

**Brief Title:** Comparative Bioavailability Study of Tablet and Granule Formulations of ADC189 and the Study of Ultra-high Dose

**Official Title:** A Comparison Study of ADC189 Bioavailability Between Tablet and Granule in Healthy Chinese Adult Male Subjects, and the Safety and Pharmacokinetics of Ultra-high Dose ADC189

#### Organization Study ID Info
**ID:** ADC-DNXV-189-GR
#### Organization
**Class:** INDUSTRY
**Full Name:** Jiaxing AnDiCon Biotech Co.,Ltd
### Status Module
#### Completion Date
**Date:** 2024-07-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-22

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-07-03

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-03-12

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-19
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Jiaxing AnDiCon Biotech Co.,Ltd

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** Part 1 of this study will compare the pharmacokinetic performance of tablet and granule formulations of ADC189 under fasted conditions in healthy volunteers. A randomized, two-period, two-treatment crossover design is used. In each period, each volunteer will receive a single oral dose of the tablet or granule formulation without food.

The purpose of Part 2 study is to determine the safety and pharmacokinetics of ultra high dose of ADC189 in healthy subjects.

**Detailed Description:** In Part 1 study, a total of 32 subjects were randomly divided into two groups, A and B, with 16 subjects in each group. After a 28-day screening period, on the first day of Period 1 (D1), subjects in group A took ADC189 granules (a single oral dose, 45mg), and subjects in group B took ADC189 tablets (a single oral dose, 45mg), all subjects were under fasted conditon. In Period 2, two groups will change to the fomulation which is different in Period 1 respectively, and all the steps will keep the same as Period 1. Each period lasts for 15 days, and have a 7-day interval between 2 periods. Blood samples will be taken, pharmacokinetic and saftey profiles will be observed.

In Part 2 study, the ultra high dose of ADC189 (a single oral dose, 180mg) will applied in 8 healty adult male subjects. The pharmacokinetic and saftey profiles will be observed during the following 15 days, and blood sample will be taken.

### Conditions Module

**Conditions:**

- Healthy Volunteer

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** CROSSOVER

##### Masking Info

**Masking:** NONE

**Primary Purpose:** OTHER

#### Enrollment Info

**Count:** 40

**Type:** ESTIMATED

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 16 patients.

**Intervention Names:**

- Drug: ADC189 tablet

- Drug: ADC189 granules

**Label:** ADC189 tablet Group A

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** 16 patients.

**Intervention Names:**

- Drug: ADC189 tablet

- Drug: ADC189 granules

**Label:** ADC189 granules Group B

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** 8 patients.

**Intervention Names:**

- Drug: ADC189 180mg

**Label:** ADC189 180mg Group

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- ADC189 granules Group B

- ADC189 tablet Group A

**Description:** ADC189 tablet, 45 mg, single oral dose in each Group. (Part 1 study)

**Name:** ADC189 tablet

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- ADC189 granules Group B

- ADC189 tablet Group A

**Description:** ADC189 granules, 45 mg, single oral dose in each Group. (Part 1 study)

**Name:** ADC189 granules

**Type:** DRUG

#### Intervention 3

**Arm Group Labels:**

- ADC189 180mg Group

**Description:** ADC189 tablet, 180 mg, single oral dose. (Part 2 study)

**Name:** ADC189 180mg

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** ADC189 plasma exposure, area under the concentration-time curve

**Measure:** ADC189 Granules

**Time Frame:** 15 days

**Description:** ADC189 plasma exposure, area under the concentration-time curve

**Measure:** ADC189 Tablet

**Time Frame:** 15 days

**Description:** Single dose of 180mg ADC189 tablet plasma exposure, area under the concentration-time curve

**Measure:** ADC189 Ultra high dose

**Time Frame:** 15 days

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* 1. Healthy male subjects aged 18-45 years old
* 2. Male subjects weight over 50 kg

Exclusion Criteria:

* 1. Any other clinically relevant abnormalities, concomitant diseases or ongoing medical conditions
* 2. Have a history of drug abuse in the past five years or use drugs in the three months prior to screening
* 3. Blood donation or blood loss \> 400 mL in 3 months before screening

**Healthy Volunteers:** True

**Maximum Age:** 45 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** zhao4wei2@hotmail.com

**Name:** Zhao Wei

**Phone:** 0531-89268212

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Jinan

**Contacts:**

***Contact 1:***

- **Name:** Wei Zhao, Dr

- **Role:** CONTACT

**Country:** China

**Facility:** Zhao Wei

**State:** Shang Dong

**Status:** RECRUITING

**Zip:** 250000

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-31
