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

ClinicalTrials.gov ID: NCT05547503

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Official title

A Double-blind, Placebo-controlled, Study of the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses of Oral AFA-281 (Phase I Part 1) and Multiple Ascending Doses of Oral AFA-281 (Phase I Part 2) in Healthy Volunteers

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT05547503
Recruitment status: Completed
Study type: Interventional
Phase: Phase 1
Lead sponsor: Afasci Inc; Industry
Enrollment: 64 participants

Conditions and interventions

Conditions

Interventions

AFA-281 Drug

Drug

Eligibility (public fields only)

Age range: 18 Years to 65 Years
Sex: All
Healthy volunteers: Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Apr 11, 2023 (Actual)
Primary completion: Dec 4, 2024 (Actual)
Completion: May 14, 2025 (Actual)
Last update posted: Oct 21, 2025

2023 – 2025

United States locations

U.S. sites: 1
U.S. states: 1
U.S. cities: 1

Facility	City	State	ZIP	Site status
CenExcel CNS	Los Alamitos	California	90720	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT05547503, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Oct 21, 2025 · Synced Nov 13, 2026