Comparative Bioavailability Study of Tablet and Granule Formulations of ADC189 and the Study of Ultra-high Dose

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteer
• Intervention / Treatment: Drug: ADC189 tablet; Drug: ADC189 granules; Drug: ADC189 180mg

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.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shang Dong
    • Jinan, Shang Dong, China, 250000
      • Zhao Wei

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ADC189 tablet Group A; 16 patients.	Drug: ADC189 tablet; ADC189 tablet, 45 mg, single oral dose in each Group. (Part 1 study); Drug: ADC189 granules; ADC189 granules, 45 mg, single oral dose in each Group. (Part 1 study)
Experimental: ADC189 granules Group B; 16 patients.	Drug: ADC189 tablet; ADC189 tablet, 45 mg, single oral dose in each Group. (Part 1 study); Drug: ADC189 granules; ADC189 granules, 45 mg, single oral dose in each Group. (Part 1 study)
Experimental: ADC189 180mg Group; 8 patients.	Drug: ADC189 180mg; ADC189 tablet, 180 mg, single oral dose. (Part 2 study)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ADC189 Granules	ADC189 plasma exposure, area under the concentration-time curve	15 days
ADC189 Tablet	ADC189 plasma exposure, area under the concentration-time curve	15 days
ADC189 Ultra high dose	Single dose of 180mg ADC189 tablet plasma exposure, area under the concentration-time curve	15 days

Collaborators and Investigators

• Sponsor: Jiaxing AnDiCon Biotech Co.,Ltd

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2024
• Primary Completion (Actual): September 22, 2024
• Study Completion (Actual): September 22, 2024

Study Registration Dates

• First Submitted: May 19, 2024
• First Submitted That Met QC Criteria: May 22, 2024
• First Posted (Actual): May 24, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 17, 2025
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: ADC-DNXV-189-GR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No