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

Last updated: October 13, 2024
Sponsor: Afasci Inc
Overall Status: Active - Recruiting

Phase

1

Condition

Pain

Pain (Pediatric)

Treatment

AFA-281

Clinical Study ID

NCT05547503
AFA-281-001
  • Ages 18-65
  • All Genders
  • Accepts Healthy Volunteers

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants must be in good general health with no significant medical history andhave no clinically significant abnormalities on physical examination at screeningand/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/m2inclusive.

  • Participants must have clinical laboratory values within normal range asspecified by the testing laboratory, unless deemed not clinically significantby the Investigator or delegate.

  • Participants must have an ECG without clinically significant pathologicabnormalities.

Exclusion

Exclusion Criteria:

  • Participants with significant medical history or clinically significantabnormalities

  • Participants with clinically significantly pathologic abnormalities

  • Participants with ECG abnormalities

Study Design

Total Participants: 58
Treatment Group(s): 1
Primary Treatment: AFA-281
Phase: 1
Study Start date:
April 11, 2023
Estimated Completion Date:
February 28, 2025

Study 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.

Connect with a study center

  • CenExcel CNS

    Los Alamitos, California 90720
    United States

    Active - Recruiting

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