Testing AFA-281 in healthy volunteers for pain management
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
PHASE1 · Afasci Inc · NCT05547503
This study is testing a new oral medication called AFA-281 in healthy volunteers to see if it can safely help manage pain.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 58 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Afasci Inc (industry) |
| Locations | 1 site (Los Alamitos, California) |
| Trial ID | NCT05547503 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and tolerability of AFA-281, an oral medication, in healthy volunteers through two phases. In Phase I Part 1, participants receive single ascending doses of AFA-281 or a placebo, with extensive monitoring of pharmacokinetics and safety. Phase I Part 2 involves administering multiple doses of AFA-281 over 14 to 21 days to further assess its safety and pharmacokinetic profile. The study aims to gather critical data on how the drug behaves in the body and its potential effects.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy adults aged 18-65 with a BMI between 18.0 and 30.0 kg/m2.
Not a fit: Patients with significant medical histories or clinically significant abnormalities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new pain management options for patients suffering from neuropathic and inflammatory pain.
How similar studies have performed: Other studies have shown promise with similar approaches in evaluating new pain management therapies, but this specific drug is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Los Alamitos, California
- CenExcel CNS — Los Alamitos, California, United States (RECRUITING)
Study contacts
- Study coordinator: Dennis Gilman, PhD
- Email: dpgilman@clindm-llc.com
- Phone: 7752250561
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pain, Neuropathic, Pain, Inflammatory