Single Ascending Dose to Study the Safety, Tolerability, PK and PD Effects of AEF0117
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is designed to evaluate the safety, tolerability, pharmacokinetics (PK) and
      pharmacodynamics (PD) of escalating single oral doses of AEF0117 in healthy adult male and
      female subjects.
    

Detailed description: 
      The overall goal of this protocol is to evaluate the safety, tolerability, pharmacokinetics
      (PK) and pharmacodynamics (PD) of escalating single oral doses of AEF0117 in healthy adult
      male and female subjects. This will be a single center study in healthy adult male and female
      subjects. The study design will be a double-blind, randomized, placebo-controlled, single
      period, parallel group, single dose escalation with AEF0117.

      Four dose levels are planned for the study with 8 subjects (6 active and 2 placebo, 3:1
      ratio) per dose level:

      Dose Level I - 0.2 mg single oral dose of AEF0117 given on the morning of Day 1 Dose Level II
      - 0.6 mg single oral dose of AEF0117given on the morning of Day 1 Dose Level III - 2 mg
      single oral dose of AEF0117 given on the morning of Day 1 Dose Level IV - 6 mg single oral
      dose of AEF0117 given on the morning of Day 1 The planned dose escalation schema may be
      amended based on the emerging PK and safety data. Each subject will participate in only one
      dose group.

      In each dosing cohort, 2 sentinel subjects (randomized 1 AEF0117: 1placebo) will be dosed and
      observed for safety monitoring for 24 hours prior to initiating dosing in the remaining 6
      subjects (randomized 5 AEF0117: 1 placebo).

      The first cohort will be administered 0.2mg. Administration of AEF0117 to the subsequent dose
      cohorts,0.6 mg(Cohort II), 2 mg (Cohort III), and 6 mg (Cohort IV) doses should not occur
      before participants in the previous dose cohort have been treated and data i.e. safety
      results from those participants are reviewed in accordance with the protocol.

      Serial blood sample collections will be performed for 144 hours after dose administration for
      PK analysis, and for 48 hours after dose administration for PD analysis.

      Subjects will be admitted to the research clinic at midday prior to dosing (Day -1) and
      remain in-house until Day 8. Randomized subjects will receive a single dose of AEF0117 on Day
      1. PK samples and safety assessments will be performed pre-dose and at different times post
      dose. Safety monitoring (physical examinations, vital sign measurement, 12-lead
      electrocardiograms [ECGs], clinical safety laboratory tests, and adverse event monitoring)
      will be performed throughout the study. Psychometrics (Bond & Lader VAS, ARCI, POMS) and
      C-SSRS tests will be performed.
    

Intervention name(s): AEF0117; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 0.2, 0.6, 2, or 6mg of AEF0117; Matching capsule placebo
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment