Phase 1/2 Trial of AEF0217 in Participants With Down Syndrome

Summary

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.

Timeline

Start

2022-12-15

Primary completion

2024-10-07

Completion

2024-10-07

Outcome

Met primary endpoint

release “Phase 1/2 randomized, double-blind, placebo-controlled study in young adults with Down syndrome (29 participants aged 18 to 32 years), AEF0217 showed a very favorable safety” aelisfarma.com ↗

Drugs

Indications