RecruitingPhase 2NCT07303907

A Phase 2A Trial of DT402 for Autism Spectrum Disorder

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

Sponsor

Definium Therapeutics US, Inc.

Enrollment

20 participants

Start Date

Dec 3, 2025

Study Type

INTERVENTIONAL

Conditions

Autism Spectrum Disorder ASD

Summary

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

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria3

Diagnosis of ASD per records as confirmed by standard semi-structured interview for Autism diagnosis (eg, Autism Diagnostic Observation Schedule-Second Edition)
Male or Female aged 18 to 65
Presents with clinically significant deficits in socialization and communication as determined by Social Responsiveness Scales (SRS-2) ≥66

Exclusion Criteria4

Has uncorrected abnormalities in eye movement, alignment, or acuity or atypical eye features that could interfere with eye tracking
First degree relative with or lifetime history of a psychotic disorder or bipolar disorder
Current diagnosis of alcohol or substance use disorder (excluding nicotine and caffeine)
Any clinically significant unstable illness

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Interventions

DRUGDT402 (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