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

NCT05748405 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-10-10

No results posted yet for this study

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

DRUG

Placebo

Matching Tablets

DRUG

AEF0217

Tablets of 100 mcg AEF0217

Sponsors & Collaborators

Principal Investigators

  • Rafael De la Torre Fornell · IMIM

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-15
Primary Completion
2024-10-07
Completion
2024-10-07

Countries

  • Spain

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05748405 on ClinicalTrials.gov