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

AnDiCon Biotech

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: ADC189 180mg; Drug: ADC189 granules; Drug: ADC189 tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT06428903

ADC-DNXV-189-GR

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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48 participants in 3 patient groups

ADC189 tablet Group A

Experimental group

Description:

16 patients.

Treatment:

Drug: ADC189 tablet

Drug: ADC189 granules

ADC189 granules Group B

Experimental group

Description:

16 patients.

Treatment:

Drug: ADC189 tablet

Drug: ADC189 granules

ADC189 180mg Group

Experimental group

Description:

8 patients.

Treatment:

Drug: ADC189 180mg