NCT07303907 A Phase 2A Trial of DT402 for Autism Spectrum Disorder
| NCT ID | NCT07303907 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Definium Therapeutics US, Inc. |
| Condition | Autism Spectrum Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-12-03 |
| Primary Completion | 2027-08 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 20 participants in total. It began in 2025-12-03 with a primary completion date of 2027-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
A Phase 2A Trial of DT402 Open-Label Study in Adults with Autism Spectrum Disorder
Eligibility Criteria
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
Contact & Investigator
Definium Therapeutics Clinical Trials Information Requests
✉ clinicaltrials@definiumtx.com📞 1-332-282-0479
Frequently Asked Questions
Who can join the NCT07303907 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Autism Spectrum Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07303907 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07303907 currently recruiting?
Yes, NCT07303907 is actively recruiting participants. Contact the research team at clinicaltrials@definiumtx.com for enrollment information.
Where is the NCT07303907 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT07303907 clinical trial?
NCT07303907 is sponsored by Definium Therapeutics US, Inc.. The trial plans to enroll 20 participants.