A Phase 2A Trial of DT402 for Autism Spectrum Disorder
A Phase 2A Trial of DT402 Open-Label Study in Adults with Autism Spectrum Disorder
| Condition(s) | Autism Spectrum Disorder, ASD |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | A Phase 2A Trial of DT402 Open-Label Study in Adults with Autism Spectrum Disorder |
| Who can participate | 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 |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Lead sponsor | Definium Therapeutics US, Inc. |
| Locations | New York, New York, United States |
| Start date | 2025-12-03 |
| NCT ID | NCT07303907 |
| Official listing | https://clinicaltrials.gov/study/NCT07303907 |