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:
Participant gender:
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.