Delving into the Latest Updates on AEF-0217 with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

AEF 0217, AEF-0217

Target

CB1

Mechanism

CB1 antagonists(Cannabinoid CB1 receptor antagonists)

Therapeutic Areas

Nervous System DiseasesCongenital DisordersOther Diseases

Active Indication

Down Syndrome

Inactive Indication-

Originator Organization

Aelis Farma SA

Active Organization

Aelis Farma SA

Inactive Organization-

Drug Highest PhasePhase 1/2

First Approval Date-

Regulation-

Login to view timeline

AEF0217-102 clinical trial assesses the safety, tolerability, plasma exposure and preliminary indications of pharmacodynamic activity of AEF0217 in female and male adult participants with Down syndrome between 18 and 35 years old.
The trial AEF0217-102 is a double-blind, randomized, placebo-controlled, multiple-dose, 4-week phase 1/2 study. After a screening period, the participant will be randomised and will take an oral dose of AEF0217 0.2mg or placebo once a day for 28 days.

Start Date15 Dec 2022

Sponsor / Collaborator

Aelis Farma SA

NCT05170737 / CompletedPhase 1

A First-In-Human Phase I Study in 3 Parts: Randomized, Double-blind, Placebocontrolled, Sequential Group Investigation of the Safety, Tolerability, Pharmacokinetics of AEF0217 After Oral, Single and Multiple Ascending Doses, and an Open Label, Cross-over Investigation of the Effect of Food on the Bioavailability of AEF0217 in Healthy Volunteers.

This trial is divided in 3 parts: FIH-SAD (Single Ascending Doses), FIH-MAD (Multiple Ascending Doses) and FIH-FE (Food effects). FIH-SAD will start first. The start of FIH-MAD will await the results of at least three cohorts from the FIHSAD study before initiated. The starting dose of the FIH-MAD will have been shown to be well tolerated and one dose level lower than the highest dose for which safety, tolerability and pharmacokinetic (PK) data are available. FIH-FE will be the last to start after the completion of FIH-SAD and conducted in parallel with parts of FIH-MAD.

Start Date01 Oct 2021

Sponsor / Collaborator

Aelis Farma SA

100 Clinical Results associated with AEF-0217

Login to view more data

100 Translational Medicine associated with AEF-0217

Login to view more data

100 Patents (Medical) associated with AEF-0217

Login to view more data

100 Deals associated with AEF-0217

Login to view more data