Actively Recruiting
An Open-label Study Evaluating DT402 in Adults With Autism Spectrum Disorder
Led by Definium Therapeutics US, Inc. · Updated on 2026-04-06
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of DT402, a psychoactive drug, in adults diagnosed with Autism Spectrum Disorder (ASD). This Phase 2A open-label study will involve about twenty adults aged 18 to 65 years. The study aims to understand how a single dose of DT402 affects symptoms related to socialization and communication difficulties common in ASD. Participants will receive a single 200 mg dose of DT402, which works mainly by releasing certain brain chemicals such as serotonin, norepinephrine, and dopamine. The study is conducted at a single center without any placebo or blinding, focusing on observing the drug's effects after one administration. Throughout the study, participants will be monitored at several time points up to 24 hours after dosing and again on day 15. Researchers will assess changes in symptom severity using an 11-point rating scale and gather subjective feedback through a drug effects questionnaire. Blood samples will also be collected to analyze the drug's levels and behavior in the body. The total participation will last until the day 15 follow-up after dosing.
CONDITIONS
Brief Title
A Phase 2A Trial of DT402 for Autism Spectrum Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of Autism Spectrum Disorder confirmed by a standard interview such as the Autism Diagnostic Observation Schedule
- Male or female aged 18 to 65 years
- Clinically significant socialization and communication deficits with a Social Responsiveness Scale (SRS-2) score of 66 or higher
You will not qualify if you...
- Uncorrected eye movement, alignment, or sight abnormalities that interfere with eye tracking
- First-degree relative with a history of psychotic or bipolar disorder
- Current diagnosis of alcohol or substance use disorder (excluding nicotine and caffeine)
- Any clinically significant unstable illness
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants receive a single administration of DT402 and are monitored for effects.
1 visit (in-person) with assessments before dosing and multiple assessments up to 24 hours post-dose
Duration - 15 days
Participants are assessed for effects and safety 15 days after treatment.
1 visit (in-person) on day 15
Trial Site Locations
Total: 1 location
1
Spectrum Neuroscience and Treatment Institute
New York, New York, United States, 10021
Actively Recruiting
Research Team
D
Definium Therapeutics Clinical Trials Information Requests
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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