Phase I Single Ascending Dose and Multiple Ascending Doses of Oral AFA-281 in Healthy Volunteers

Launched by AFASCI INC · Sep 16, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called AFA-281, which is being tested to see how safe it is and how well it is tolerated in healthy volunteers. The trial is divided into two parts. In the first part, a small group of volunteers will receive either AFA-281 or a placebo (a pill with no active medication) to compare the effects. The goal is to understand how the body processes AFA-281 and to ensure it is safe to use. In the second part, if the results from the first part are positive, participants will take AFA-281 daily for 14 to 21 days to gather more information on its safety and how it behaves in the body over time.

To be eligible for this trial, participants must be generally healthy, with no major health issues, and have a Body Mass Index (BMI) between 18.0 and 30.0 kg/m². They should also have normal lab results and a healthy heart rhythm. This trial is open to adults of all genders aged between 18 and 65. If you join, you can expect regular check-ups and monitoring to ensure your safety throughout the study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Participants must be in good general health with no significant medical history and have no clinically significant abnormalities on physical examination at screening and/or before administration of the initial dose of study drug.
• • Participants must have a Body Mass Index (BMI) between 18.0 and 30.0 kg/m2 inclusive.
• • Participants must have clinical laboratory values within normal range as specified by the testing laboratory, unless deemed not clinically significant by the Investigator or delegate.
• • Participants must have an ECG without clinically significant pathologic abnormalities.
• Exclusion Criteria:
• • Participants with significant medical history or clinically significant abnormalities
• • Participants with clinically significantly pathologic abnormalities
• • Participants with ECG abnormalities