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

NCT ID: NCT05547503

Last Updated: 2025-10-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-11
• Study Completion Date: 2025-05-14

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo Control

Double blind placebo control

Group Type: PLACEBO_COMPARATOR

AFA-281

Intervention Type: DRUG

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)

AFA-281

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.

Group Type: EXPERIMENTAL

AFA-281

Intervention Type: DRUG

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)

Interventions

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)

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cognitive Research Corporation

INDUSTRY

Sponsor Role: collaborator

Afasci Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xinmin Xie, MD, PhD

Role: STUDY_CHAIR

Afasci Inc

Locations

CenExcel CNS

Los Alamitos, California, United States

Countries

United States

Other Identifiers

AFA-281-001

Identifier Type: -

Identifier Source: org_study_id