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

Completed · Phase 1 · Has a placebo group

Conditions studied: Pain, Neuropathic, Pain, Inflammatory

In brief

Phase I Part 1 (single ascending dose): Double-blind dosing will occur in healthy volunteers in 4 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. At the end of the Part 1 study is 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 to 21 consecutive days in 3 cohorts. At scheduled intervals after dosing, and at the end of the cohort's study period to evaluate the safety and tolerability and the pharmacokinetic profile of AFA-281.

Key facts

Study ID

NCT05547503

Run by

Afasci Inc

People needed

64

Starts

2023-04-11

Expected to finish

2025-05-14

Last updated by the study team

2025-10-21

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• Participants with significant medical history or clinically significant abnormalities
• Participants with clinically significantly pathologic abnormalities
• Participants with ECG abnormalities

Where it is running

• CenExcel CNS — Los Alamitos, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.