Effects of Intranasal Administration of a Single Dose of Oxytocin Using a Novel Device in Adults With Autism Spectrum Disorder

This is an interventional basic science trial for Autism Spectrum Disorder focused on measuring oxytocin, social cognition Read More

Inclusion Criteria:

• Male subjects between the ages of 18 and 35, both inclusive, with a confirmed diagnosis of autism spectrum disorder (ASD) diagnosis.
• Subjects must be in good general health, as determined by the investigator.
• Subject's pre-study physical examination, vital signs and electrocardiogram (ECG) must not show any clinically significant abnormalities as determined by the investigator.
• Subjects must be able to communicate well with the Investigator, to understand and comply with the requirements of the study, and to understand the oral and written patient information
• Provision of a signed, written informed consent.

Exclusion Criteria:

• Subjects showing major septal deviation or a significantly altered nasal epithelium.
• Subjects with evidence of previous nasal disease, surgery, and dependence on inhaled drugs.
• Subjects with current significant nasal congestion due to common colds.
• Subjects with a clinically relevant history of significant hepatic, renal, endocrine, cardiac, nervous, pulmonary, haematological or metabolic disorder.
• Psychiatric co-morbidity that requires intervention (e.g., psychosis spectrum disorders, suicide intent)
• Systemic illness requiring treatment within 2 weeks prior to Study Day 1.
• History of significant drug or alcohol abuse (as per WHO Alcohol use disorder identification test and drug use disorder identification test criteria) Subjects with a positive screen for alcohol or drugs of abuse at screening/admission will be excluded from participation in the study.
• Abnormal laboratory values which is deemed clinically significant by investigator.
• Full scale IQ < 75 (due to the prerequisite ability to complete self report measures).
• Known allergic reactions or hypersensitivity to any component of the study medication in the nasal spray, such as propyl parahydroxybenzoate (E216), methyl parahydroxybenzoate (E218) and chlorobutanol hemihydrate.
• Participation in any (other) clinical trial with an investigational medicinal product or medical device within 3 months prior to randomisation.
• Other unspecified reasons that, in the opinion of the investigator or the sponsor make the subject unsuitable for enrollment.