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RecruitingPhase 2

A Phase 2A Trial of DT402 for Autism Spectrum Disorder

NCT07303907 · Definium Therapeutics US, Inc.

Recruiting
Status
Accepting participants
Phase 2
Phase
20
Target enrolment
1
Study sites
1 US states

What it is testing

Summary

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

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Change from Baseline in 11-point Numerical Rating Scale (NRS) scores

    Measured over Baseline, pre-dose and 2, 4, 6, 8, and 24 hours post-dose and day 15

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 65 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: 1. Diagnosis of ASD per records as confirmed by standard semi-structured interview for Autism diagnosis (eg, Autism Diagnostic Observation Schedule-Second Edition) 2. Male or Female aged 18 to 65 3. Presents with clinically significant deficits in socialization and communication as determined by Social Responsiveness Scales (SRS-2) ≥66 Exclusion Criteria: 1. Has uncorrected abnormalities in eye movement, alignment, or acuity or atypical eye features that could interfere with eye tracking 2. First degree relative with or lifetime history of a psychotic disorder or bipolar disorder 3. Current diagnosis of alcohol or substance use disorder (excluding nicotine and caffeine) 4. Any clinically significant unstable illness

Where

1 study site

FacilityCityRegionCountry
Spectrum Neuroscience and Treatment InstituteNew YorkNew YorkUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT07303907 on ClinicalTrials.gov →

Last updated in the registry 2026-04-06. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits