NCT05748405

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

A Double-blind, Randomized, Placebo-controlled, 4-week, Phase 1/2 Trial in Young Adult Participants With Down Syndrome to Assess the Safety, Tolerability, Plasma Exposure, and Preliminary Indications of Pharmacodynamic Activity of AEF0217

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Aelis Farma · Industry
• Sex: All
• Age: 18 Years – 35 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Down Syndrome

Interventions

Type	Name	Description
DRUG	Placebo	Matching Tablets
DRUG	AEF0217	Tablets of 100 mcg AEF0217

Timeline

• Start date: 2022-12-15
• Primary completion: 2024-10-07
• Completion: 2024-10-07
• First posted: 2023-02-28
• Last updated: 2024-10-10

Locations

3 sites across 1 country: Spain