Single Ascending Dose or 14-day Study With AFA-281 in Healthy Volunteers

• Status: Not yet recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Phase I Part 1 (single dose):

Double-blind dosing will occur in healthy volunteers in 5 cohorts of 8 subjects each. Six subjects in each cohort will be randomized to receive AFA-281 and 2 subjects will be randomized to receive the matching placebo. Single dose escalation at: 20 mg, 40 mg, 80 mg, 160 mg, and 300 mg (total daily dose via oral capsule). Parameters evaluated include: baseline physical examination, vital signs, clinical chemistry and hematology tests, and electrocardiograms (ECGs) prior to dosing, at scheduled intervals after dosing, and at the end of the cohort to evaluate the safety and tolerability of AFA-281. Following completion of each cohort, bioanalytical analyses will be conducted to evaluate the pharmacokinetic profile.

Phase I Part 2 (multiple dose for 14 days):

Pending the results from Part 1, healthy volunteers will be administered AFA-281 for 14 consecutive days in 3 cohorts. Six subjects in each cohort will be randomized to receive AFA-281 twice daily and two subjects will be randomized to receive the matching placebo twice daily. Routine clinical monitoring will occur as in Part 1. Baseline physical examination, vital signs, clinical lab tests, and ECGs will be performed prior to dosing, at scheduled intervals after dosing, and at the end of the cohort's study period to evaluate the safety and tolerability of AFA-281 and the pharmacokinetic profile of AFA-281.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Afasci Inc

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