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New pain pill AFA-281 takes first step in human safety trial

NCT ID NCT05547503

Knowledge-focused Sponsor: Afasci Inc Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage study tested the safety and tolerability of a new drug called AFA-281 in 64 healthy volunteers. Participants received either a single dose or multiple doses over 14-21 days. The goal was to check for side effects and measure how the drug behaves in the body, not to treat pain. Results will help decide if further studies in people with pain are warranted.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
AFA-281
What this could lead to
If successful, this could pave the way for further studies testing AFA-281 as a potential treatment for nerve or inflammatory pain.
What could go wrong
This is a very early Phase 1 trial in healthy volunteers, not patients. It only checks safety and how the drug moves through the body, not whether it works for pain. Many early-stage drugs fail in later trials.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

64 people

The number who actually took part.

Started

Apr 2023

Finished

May 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

neuralgia Pain

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pain, inflammatory Pain, neuropathic

Contacts and locations

Locations

  • CenExcel CNS

    Los Alamitos, California, 90720, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.