Pain, NeuropathicPhase 1NCT05547503
Phase I Single Ascending Dose and Multiple Ascending Doses of Oral AFA-281 in Healthy Volunteers
A Phase 1 study testing AFA-281 in people with Pain, Neuropathic and Pain, Inflammatory, run by Afasci Inc at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Neuropathic, Pain, Inflammatory
- What is being tested?
- AFA-281
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Apr 2023to 14 May 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Participants with significant medical history or clinically significant abnormalities
- Participants with clinically significantly pathologic abnormalities
- Participants with ECG abnormalities
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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.
Read the detailed description
Phase I Part 1 (single ascending dose):
Healthy volunteers will be admitted to the clinical research unit on Day -1. There will be five cohorts with 8 subjects per cohort. Six subjects per cohort will receive AFA-281 at one of 4 doses and 2 will receive placebo. Oral capsules will be administered on the morning of Day 1, following a 10-hour fast. Blood draws for assessment of Pharmacokinetic parameters will occur 0.2-1 hr pre-dose and at 0.5-, 1-, 2-, 3-, 4-, 8-, 10, 12-, 16-, 24-, 36-, 48-hr, and up to 72-hr post-dose. Vital signs will be collected at scheduled times following dosing. A 12-lead ECG will be obtained pre-dose and scheduled at 2, 4, 8, 24 hr, and 3- or 4 days post- dose. Various clinical laboratory tests will be drawn on Day -1, within 1 hr prior to dosing, and at scheduled timepoints after dosing while the volunteer is housed in the research center. Subjects of Cohorts 1 - 3 will be released following completion of blood draws and safety assessments up to 48 hours and Cohorts 4 and 5 subjects will return for 72-hour blood draws and Day 4 ECG and safety assessment.
Phase I Part 2 (multiple ascending doses - 14 days):
After assessment of the safety data from the single dose Phase I Part 1, healthy volunteers will be randomized into 3 cohorts with 8 subjects per cohort. Five subjects per cohort will receive AFA-281 and 3 will receive placebo. Oral capsules will be administered in dose titration and split daily dose in fours time daily (QID) for 14 - 21 consecutive days. Routine clinical monitoring will occur as in Part 1. Baseline physical examination, vital signs, clinical lab tests, and ECGs will be performed prior to dosing, 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. Reports of potential adverse events will be elicited, and vital signs and 12-lead ECG will be measured in a similar manner to Part 1. Similarly, clinical laboratory tests will be drawn prior to and after dosing.
- Conditions
- Pain, Neuropathic, Pain, Inflammatory
- Being tested
- AFA-281
- Medical subject headings
- Neuralgia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AFA-281Drug
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)
| Study group | Role | What they receive |
|---|---|---|
| Placebo Control | Placebo comparator | Double blind placebo control Receives: Drug: AFA-281 |
| AFA-281 | Experimental | Part 1: AFA-281 administered as an oral capsule at 5 dose levels for one day.
Part 2: AFA-281 administered as an oral capsule at 3 dose levels twice daily for 14 consecutive days. Doses will be determined after completion of Part 1. Receives: Drug: AFA-281 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-Related Adverse Events
Number of participants with treatment-related adverse events will be assessed using CTCAE v5.0
Measured: Predose and Up to 72 hours after dose
Heart rate
Heart rate as one of vital signs will be measured
Measured: Predose and Up to 72 hours after dose
Body temperature
Body temperature (0C) as one of vital signs will be measured
Measured: Predose and Up to 72 hours after dose
Blood Pressure
Blood pressure as one of vital signs will be measured
Measured: Predose and Up to 72 hours after dose
Electrocardiogram (ECG)
Triplicate 12-lead ECG will be measured to evaluate electrical activity of the heart
Measured: Pre-dose and up to 72 hours after dose
Blood chemistry
Blood chemistry parameters will be measured
Measured: Pre-dose and up to 72 hours after dose
Hematology
Hematology parameters will be measured
Measured: Pre-dose and up to 72 hours after dose
Coagulation
Coagulation parameters (PT/INR, PTT) will be measured
Measured: Pre-dose and up to 72 hours after dose
Urinalysis
Urinalysis parameters will be measured using dipstick and microscopic examination.
Measured: Pre-dose and up to 72 hours after dose
Blood maximum plasma concentration (Cmax) of the study drug
Pharmacokinetics parameter Cmax will be measured to assess drug exposure levels in blood
Measured: Pre-dose and up to 72 hours after dose
Blood study drug half-life (t1/2)
Pharmacokinetics parameter t1/2 will be measured to evaluate drug half-life in the blood
Measured: Pre-dose and up to 72 hours after dose
Area under the plasma concentration versus time curve (AUC) of the study drug
Pharmacokinetics parameter AUC will be measured
Measured: Pre-dose and up to 72 hours after dose
Secondary outcomes (5)
A dose and exposure relationship
Doses of study drug and blood exposure levels will be analyzed to determine dose proportionality.
Measured: Pre-dose and up to 72 hours after dose
Tmax of the study drug (parent compound) in blood
Pharmacokinetics parameter Time at which Cmax of the study drug appeared will be determined.
Measured: Up to 72 hours after dose
Plasma Concentration (Cmax) of the major metabolite in blood
Pharmacokinetics parameter Cmax of a major metabolite will be measured.
Measured: Up to 72 hours after dose
Area under the plasma concentration versus time curve (AUC) of the major metabolite in blood
Pharmacokinetics parameter AUC of a major metabolite will be measured.
Measured: Up to 72 hours after dose
The major metabolite half-life (t1/2) in blood
Pharmacokinetics parameter t1/2 of a major metabolite will be measured.
Measured: Up to 72 hours after dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2022
- Study start11 Apr 2023
- Primary completion4 Dec 2024
- Study completion14 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, NeuropathicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Part 1: Single escalation dose Part 2: Multiple escalation doses for 14 days
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Afasci Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cognitive Research Corporation
- Responsible party
- Sponsor
- Investigators
- Xinmin Xie, MD, PhD, Study chair, Afasci Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05547503
- Sponsor's protocol ID
- AFA-281-001
- Status last verified
- Oct 2025
- First submitted
- 14 Sep 2022
- Last updated
- 21 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: One year after completion of the study and 6 months after publication
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05547503
- Acronym / sponsor ID
- AFA-281-001
- Conditions
- Pain, Neuropathic, Pain, Inflammatory
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Afasci IncIndustry (pharma, biotech, devices)
- Collaborators
- Cognitive Research Corporation
- Study start
- 11 Apr 2023 (actual)
- Primary completion
- 4 Dec 2024 (actual)
- Study completion
- 14 May 2025 (actual)
- First posted
- 21 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Phase I Part 1 (single ascending dose):
Healthy volunteers will be admitted to the clinical research unit on Day -1. There will be five cohorts with 8 subjects per cohort. Six subjects per cohort will receive AFA-281 at one of 4 doses and 2 will receive placebo. Oral capsules will be administered on the morning of Day 1, following a 10-hour fast. Blood draws for assessment of Pharmacokinetic parameters will occur 0.2-1 hr pre-dose and at 0.5-, 1-, 2-, 3-, 4-, 8-, 10, 12-, 16-, 24-, 36-, 48-hr, and up to 72-hr post-dose. Vital signs will be collected at scheduled times following dosing. A 12-lead ECG will be obtained pre-dose and scheduled at 2, 4, 8, 24 hr, and 3- or 4 days post- dose. Various clinical laboratory tests will be drawn on Day -1, within 1 hr prior to dosing, and at scheduled timepoints after dosing while the volunteer is housed in the research center. Subjects of Cohorts 1 - 3 will be released following completion of blood draws and safety assessments up to 48 hours and Cohorts 4 and 5 subjects will return for 72-hour blood draws and Day 4 ECG and safety assessment.
Phase I Part 2 (multiple ascending doses - 14 days):
After assessment of the safety data from the single dose Phase I Part 1, healthy volunteers will be randomized into 3 cohorts with 8 subjects per cohort. Five subjects per cohort will receive AFA-281 and 3 will receive placebo. Oral capsules will be administered in dose titration and split daily dose in fours time daily (QID) for 14 - 21 consecutive days. Routine clinical monitoring will occur as in Part 1. Baseline physical examination, vital signs, clinical lab tests, and ECGs will be performed prior to dosing, 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. Reports of potential adverse events will be elicited, and vital signs and 12-lead ECG will be measured in a similar manner to Part 1. Similarly, clinical laboratory tests will be drawn prior to and after dosing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Part 1: Single escalation dose Part 2: Multiple escalation doses for 14 days
| Arm | Type | Receives |
|---|---|---|
| Placebo Control | Placebo comparator | Drug: AFA-281Double blind placebo control |
| AFA-281 | Experimental | Drug: AFA-281Part 1: AFA-281 administered as an oral capsule at 5 dose levels for one day. Part 2: AFA-281 administered as an oral capsule at 3 dose levels twice daily for 14 consecutive days. Doses will be determined after completion of Part 1. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Participants with significant medical history or clinically significant abnormalities
- Participants with clinically significantly pathologic abnormalities
- Participants with ECG abnormalities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AFA-281Part 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) | Drug | AFA-281, Placebo Control |
Primary outcome
Treatment-Related Adverse Events
Time frame: Predose and Up to 72 hours after dose
Number of participants with treatment-related adverse events will be assessed using CTCAE v5.0
Heart rate
Time frame: Predose and Up to 72 hours after dose
Heart rate as one of vital signs will be measured
Body temperature
Time frame: Predose and Up to 72 hours after dose
Body temperature (0C) as one of vital signs will be measured
Blood Pressure
Time frame: Predose and Up to 72 hours after dose
Blood pressure as one of vital signs will be measured
Electrocardiogram (ECG)
Time frame: Pre-dose and up to 72 hours after dose
Triplicate 12-lead ECG will be measured to evaluate electrical activity of the heart
Blood chemistry
Time frame: Pre-dose and up to 72 hours after dose
Blood chemistry parameters will be measured
Hematology
Time frame: Pre-dose and up to 72 hours after dose
Hematology parameters will be measured
Coagulation
Time frame: Pre-dose and up to 72 hours after dose
Coagulation parameters (PT/INR, PTT) will be measured
Urinalysis
Time frame: Pre-dose and up to 72 hours after dose
Urinalysis parameters will be measured using dipstick and microscopic examination.
Blood maximum plasma concentration (Cmax) of the study drug
Time frame: Pre-dose and up to 72 hours after dose
Pharmacokinetics parameter Cmax will be measured to assess drug exposure levels in blood
Blood study drug half-life (t1/2)
Time frame: Pre-dose and up to 72 hours after dose
Pharmacokinetics parameter t1/2 will be measured to evaluate drug half-life in the blood
Area under the plasma concentration versus time curve (AUC) of the study drug
Time frame: Pre-dose and up to 72 hours after dose
Pharmacokinetics parameter AUC will be measured
5 secondary outcomes
A dose and exposure relationship
Time frame: Pre-dose and up to 72 hours after dose
Tmax of the study drug (parent compound) in blood
Time frame: Up to 72 hours after dose
Plasma Concentration (Cmax) of the major metabolite in blood
Time frame: Up to 72 hours after dose
Area under the plasma concentration versus time curve (AUC) of the major metabolite in blood
Time frame: Up to 72 hours after dose
The major metabolite half-life (t1/2) in blood
Time frame: Up to 72 hours after dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2025.
- Individual participant dataSharing planned: Yes. One year after completion of the study and 6 months after publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xinmin Xie, MD, PhD study chair
Afasci Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AFA-281 in people with Pain, Neuropathic and Pain, Inflammatory, run by Afasci Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment-Related Adverse Events (time frame: Predose and Up to 72 hours after dose). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2025.