NCT07303907

A Phase 2A Trial of DT402 for Autism Spectrum Disorder

An Open-label Study Evaluating DT402 in Adults With Autism Spectrum Disorder

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Definium Therapeutics US, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

A Phase 2A Trial of DT402 Open-Label Study in Adults with Autism Spectrum Disorder

Detailed description

This study will enroll approximately twenty adults with Autism Spectrum Disorder (ASD) aged 18 to 65 years of age. This is a single-center, open-label study to evaluate the effects after a single administration of DT402 to adults with ASD.

Conditions

• Autism Spectrum Disorder
• ASD

Interventions

Type	Name	Description
DRUG	DT402 (R-enantiomer of 3,4-methylenedioxymethamphetamine (MDMA))	A psychoactive substance that mediates effects mainly through a release of the monoaminergic neurotransmitters, with the greatest effect on 5-HT, followed by NE and DA

Timeline

• Start date: 2025-12-03
• Primary completion: 2027-08-01
• Completion: 2027-08-01
• First posted: 2025-12-26
• Last updated: 2026-04-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study