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

Phase 1

Completed

• Conditions: Healthy Volunteer
• Interventions: Drug: ADC189 180mg; Drug: ADC189 tablet; Drug: ADC189 granules

• Registration Number: NCT06428903
• Lead Sponsor: Jiaxing AnDiCon Biotech Co.,Ltd

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.

Study Timeline

• Study Start: 2024-03-12
• Status Verified: 2024-05
• Study First Submitted: 2024-05-19
• Study First Submitted QC: 2024-05-22
• Study First Posted: 2024-05-24
• Primary Completion: 2024-09-22
• Study Completion: 2024-09-22
• Last Update Submitted: 2025-01-17
• Last Update Posted: 2025-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
ADC189 granules Group B	ADC189 granules	16 patients.
ADC189 180mg Group	ADC189 180mg	8 patients.
ADC189 tablet Group A	ADC189 tablet	16 patients.
ADC189 tablet Group A	ADC189 granules	16 patients.
ADC189 granules Group B	ADC189 tablet	16 patients.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Zhao Wei; 🇨🇳 Jinan, Shang Dong, China