Actively Recruiting
Open-Label Phase 2A Study of DT402 in Adults Aged 18 to 65 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
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 drugs 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 drugs 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
Research Team
D
Definium Therapeutics Clinical Trials Information Requests
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