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

Launched by JIAXING ANDICON BIOTECH CO.,LTD · May 22, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a medication called ADC189 to see how well it works in two different forms: a tablet and a granule. In the first part of the study, healthy volunteers will take either the tablet or the granule without food to compare how their bodies absorb the medication. In the second part, researchers will give a very high dose of ADC189 to healthy participants to check its safety and how it behaves in the body.

To take part in this trial, volunteers must be healthy men aged between 18 and 45 years old and weigh more than 50 kilograms. Participants should be in good health with no ongoing medical issues and must not have a history of substance abuse in the past five years. During the study, participants can expect to take a single dose of the medication in a controlled setting, and their health will be monitored closely to ensure their safety. This is an important step in understanding how ADC189 can be used effectively in future treatments.

Gender

ALL

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