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

NCT05547503 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2025-10-21

No results posted yet for this study

Summary

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.

Conditions

  • Pain, Neuropathic
  • Pain, Inflammatory

Interventions

DRUG

AFA-281

Part 1: AFA-281 will be administered as a single dose at 4 dose levels (TBD) Part 2: AFA-281 will be administered twice daily for 14 - 21 days at 3 dose levels (TBD)

Sponsors & Collaborators

  • Cognitive Research Corporation

    collaborator INDUSTRY

  • Afasci Inc

    lead INDUSTRY

Principal Investigators

  • Xinmin Xie, MD, PhD · Afasci Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-04-11
Primary Completion
2024-12-04
Completion
2025-05-14
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05547503 on ClinicalTrials.gov